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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug2443 | Pioglitazone 30 mg Wiki | 0.29 |
drug1791 | Linagliptin Wiki | 0.29 |
drug3447 | Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Wiki | 0.29 |
Name (Synonyms) | Correlation | |
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drug1351 | Glycaemic levels Wiki | 0.29 |
drug3500 | Use of the pinpointIQ solution (physIQ, Inc.) Wiki | 0.29 |
drug3482 | Ultrasound of the lower limbs Wiki | 0.29 |
drug1636 | Insulin regimen Wiki | 0.29 |
drug1792 | Linagliptin 5 MG Wiki | 0.29 |
drug3679 | antidiabetic treatment Wiki | 0.29 |
drug3765 | eHealth Wiki | 0.29 |
drug3459 | Two doses of placebo at the emergency vaccination schedule Wiki | 0.29 |
drug3872 | metformin glycinate Wiki | 0.29 |
drug3062 | Sitagliptin Wiki | 0.29 |
drug3568 | Vit D Wiki | 0.29 |
drug3446 | Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Wiki | 0.29 |
drug3766 | eHealth +counselling contacts Wiki | 0.29 |
drug1454 | Hospital: Usual Care (UC) Wiki | 0.29 |
drug3526 | Vaginal fluid Covid-19 PCR test Wiki | 0.29 |
drug3453 | Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Wiki | 0.29 |
drug1827 | Lovenox 40 MG in 0.4 mL Prefilled Syringe Wiki | 0.29 |
drug3460 | Two doses of placebo at the routine vaccination schedule Wiki | 0.29 |
drug3277 | Tele-interventions related to diabetes management and mental well-being Wiki | 0.29 |
drug1589 | Immediate vs. delayed provision of antibody test results Wiki | 0.29 |
drug1453 | Hospital: DD-CA Wiki | 0.29 |
drug3452 | Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Wiki | 0.29 |
drug3465 | Two doses of placebo at the schedule of day 0,28 Wiki | 0.20 |
drug3454 | Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Wiki | 0.20 |
drug3451 | Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Wiki | 0.20 |
drug3491 | Unfractionated heparin Wiki | 0.20 |
drug2731 | RTB101 Wiki | 0.20 |
drug675 | Canakinumab Wiki | 0.20 |
drug3505 | Usual care Wiki | 0.17 |
drug4025 | standard of care Wiki | 0.17 |
drug3116 | Standard Care Wiki | 0.14 |
drug2858 | SARS-CoV-2 Wiki | 0.14 |
drug3577 | Vitamin D3 Wiki | 0.12 |
drug3574 | Vitamin D Wiki | 0.09 |
drug2514 | Placebo oral tablet Wiki | 0.05 |
drug2448 | Placebo Wiki | 0.01 |
Name (Synonyms) | Correlation | |
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D003924 | Diabetes Mellitus, Type 2 NIH | 1.00 |
D003920 | Diabetes Mellitus, NIH | 0.40 |
D024821 | Metabolic Syndrome NIH | 0.29 |
Name (Synonyms) | Correlation | |
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D004700 | Endocrine System Diseases NIH | 0.20 |
D044882 | Glucose Metabolism Disorders NIH | 0.20 |
D003922 | Diabetes Mellitus, Type 1 NIH | 0.19 |
D009767 | Obesity, Morbid NIH | 0.17 |
D008659 | Metabolic Diseases NIH | 0.17 |
D012140 | Respiratory Tract Diseases NIH | 0.06 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
D018352 | Coronavirus Infections NIH | 0.04 |
D013577 | Syndrome NIH | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0000819 | Diabetes mellitus HPO | 0.40 |
HP:0100651 | Type I diabetes mellitus HPO | 0.20 |
HP:0000818 | Abnormality of the endocrine system HPO | 0.20 |
Navigate: Correlations HPO
There are 12 clinical trials
The purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection
Description: Change in glucose control will be assessed via glucose levels obtained from blood serum samples
Measure: Changes in Glucose Llevels Time: Baseline, up to 2 weeksDescription: changes in SpO2 will be measured with a Pulseimetry, an indirect, non-invasive method
Measure: Changes in SpO2 levels Time: Baseline, up to 2 weeksDescription: Changes in IL 6 will be assessed from blood serum samples
Measure: Changes in Interleukin 6 (IL6) Time: Baseline, up to 2 weeksDescription: Changes in Chest radiography (X-ray)
Measure: Changes in chest structures Time: Baseline, up to 2 weeksINTRODUCTION In critical situations, such as the current COVID 19 pandemic, themes of fear, uncertainty and stigmatization are common and constitute barriers to appropriate medical and mental health interventions. These challenges, when faced by those who live with a chronic disease, such as diabetes mellitus (DM), can negatively influence quality of life and adherence to treatment, compromising the control of the disease. OBJECTIVES The present study aims to investigate the effectiveness of a tele-intervention during the COVID-19 pandemic in improving glycemic control, lipid profile, blood pressure levels and parameters of medication adherence, mental well-being and sleep quality in patients with type 1 DM and type 2 DM. METHODS A randomized clinical trial will be carried out with patients with a previous diagnosis of type 1 DM and type 2 DM, who are registered at the Hospital de Clínicas de Porto Alegre (HCPA). Inclusion criteria will be age greater than or equal to 18 years, collection of HbA1c in the HCPA laboratory in January, February or March 2020 and availability to receive weekly phone calls. Patients will be randomized, stratified by type of diabetes, in two groups: G1: participants will receive a tele-intervention by a case manager weekly to discuss topics related to diabetes management and mental well-being during the social distancing period ; G2: participants will receive the usual care. The primary outcome assessed will be the variation in HbA1c levels comparatively between groups, with or without a tele-guided strategy, after four months of social distancing (or as long as the recommendation of social distancing measures remains). Secondary outcomes will include experiencing confirmation of COVID-19 infection, variation in lipid profile, blood pressure levels and variation in parameters of emotional distress related to diabetes, eating disorders, medication adherence, symptoms minor psychiatric disorders and altered sleep patterns, which will be evaluated with specific and validated scales. According to the sample calculation, 150 patients will be included in the study (92 with type 2 DM and 58 with type 1 DM). Analysis by intention to treat will be performed separately for patients with type 1 DM and with type 2 DM. SCHEDULE The proposed experiment will start immediately after approval of this project by the research ethics committee. The duration of the proposed intervention is 4 months (or as long as the recommendation of social distancing measures remains. This means that the study may be completed before or after that period, based on national recommendations for social distancing in Brazil), with a data analysis plan and publication of the results until September 2020.
Description: Variation in HbA1c levels comparatively between groups after the period of social distancing measures.
Measure: Variation in HbA1c levels Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Confirmation of coronavirus infection by rapid test
Measure: COVID-19 infection Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Comparison of the lipid profile of the last year with the lipid profile after the intervention between the groups.
Measure: Variation in lipid profile Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Comparison of the blood pressure level of the last consultation with the pressure after the intervention between the groups.
Measure: Variation in blood pressure levels Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of emotional distress associated with the routine of living with diabetes - B-PAID (Brazilian Problem Areas In Diabetes Scale)
Measure: Comparison of emotional distress associated with the routine of living with diabetes after intervention between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of eating disorders - EAT - 26 SCALE (Teste de Atitudes Alimentares)
Measure: Comparison of eating disorders between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of adherence to the proposed clinical treatment - SCI R (Self-Care Inventory - revised)
Measure: Comparison of adherence to the proposed clinical treatment between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of minor psychiatric disorders - SRQ 20 (Self Report Questionnaire)
Measure: Comparison of minor psychiatric disorders between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)Description: Evaluation of sleep pattern changes - MSQ (Mini Sleep Questionnaire)
Measure: Comparison of sleep pattern changes between groups Time: 4 months (or as long as the recommendation of social distancing measures remains)The COVID-19 pathology is frequently associated with diabetes mellitus and metabolic syndrome. In the epidemic outbreak that exploded at the beginning of 2020 in the Lombardy Region, about two thirds of the patients who died from COVID-19 were affected by diabetes mellitus. COVID-19 occurs in 70% of cases with an inflammatory pathology of the airways that can be fed by a cytokine storm and result in severe respiratory failure (10% cases) and death (5%). The pathophysiological molecular mechanisms are currently not clearly defined. It is hypothesized that the transmembrane glycoprotein type II CD26, known for the enzyme activity Dipeptilpeptidase 4 of the extracellular domain, may play a main role in this condition. It is in fact considerably expressed at the level of parenchyma and pulmonary interstitium and carries out both systemic and paracrine enzymatic activity, modulating the function of various proinflammatory cytokines, growth factors and vasoactive peptides in the deep respiratory tract. Of particular interest is the fact that Dipeptilpeptidase 4 has been identified as a cellular receptor for S glycoprotein of MERS-COV. In the case of the SARS-COV 2 virus, the main receptor is the Angiotensin-Converting Enzyme 2 protein, but a possible interaction with Dipeptilpeptidase 4 also cannot be excluded. The selective blockade of Dipeptilpeptidase 4 could therefore favorably modulate the pulmonary inflammatory response in the subject affected by COVID-19. This protein is also known for the enzymatic degradation function of the native glucagon-like peptide 1, one of the main regulators of insulin secretion. This is why it is a molecular target in the treatment of diabetes (drugs that selectively inhibit Dipeptilpeptidase 4 are marketed with an indication for the treatment of type 2 diabetes). It is believed that the use of a Dipeptilpeptidase 4 inhibitor in people with diabetes and hospitalized for Covid-19 may be safe and of particular interest for an evaluation of the effects on laboratory and instrumental indicators of inflammatory lung disease. Among the drugs that selectively block Dipeptilpeptidase 4, the one with the greatest affinity is Sitagliptin.
Description: Evaluation of the time between randomization and two-point improvement on a seven-category scale (1, not hospitalized, return to normal activities; 2, not hospitalized, but unable to return to normal activities; 3, hospitalized without the need for oxygen therapy; 4, hospitalized, need for oxygen therapy; 5, hospitalized, need for non-invasive ventilatory support; 6, hospitalized, need for invasive mechanical ventilation or Extra Corporeal Membrane Oxygenation; 7, death)
Measure: Time for clinical improvement Time: 1 monthDescription: Clinical evaluation of the physiological parameter "cough" associated with acute lung disease from the start of the study to the end of the study.
Measure: Clinical parameter of acute lung disease Time: 1 monthDescription: Variation of biochemical parameter "glycemia" of acute lung disease from the beginning of the study to the end of study.
Measure: Biochemical parameter of acute lung disease Time: 1 monthDescription: Variation of the clinical parameter "oxygen saturation by the use of a pulse oximeter" of acute lung disease from the beginning of the study to the end of the study.
Measure: Clinical parameter of acute lung disease Time: 1 monthDescription: Variation of the clinical parameter "body temperature" of acute lung disease from the beginning of the study to the end of the study.
Measure: Clinical parameter of acute lung disease Time: 1 monthDescription: Variation of the clinical parameter "respiratory rate" of acute lung disease from the beginning of the study to the end of the study.
Measure: Clinical parameter of acute lung disease Time: 1 monthDescription: Variation of the clinical parameter "need for ventilatory support" of acute lung disease from the beginning of the study to the end of the study.
Measure: Clinical parameter of acute lung disease Time: 1 monthDescription: Variation of the clinical parameters "duration in days of ventilatory support, duration in days of oxygen therapy, duration in days of hospitalization, duration in days in the Intensive Care Unit, total length of stay in hospital" of acute lung disease from the beginning of the study to the end of the study.
Measure: Clinical parameters of acute lung disease Time: 1 monthDescription: Variation of the clinical parameter "blood gas analysis" of acute lung disease from the beginning of the study to the end of the study.
Measure: Clinical parameter of acute lung disease Time: 1 monthDescription: Variation of the clinical parameter "chest X ray" of acute lung disease from the beginning of the study to the end of the study.
Measure: Clinical parameter of acute lung disease Time: 1 monthDescription: Variation of the clinical parameter "PaO2/FiO2 ratio" of acute lung disease from the beginning of the study to the end of the study.
Measure: Clinical parameter of acute lung disease Time: 1 monthDescription: Variation of biochemical parameter "reactive C protein" of acute lung disease from the beginning of the study to the end of study.
Measure: Biochemical parameter of acute lung disease Time: 1 monthDescription: Variation of biochemical parameter "blood count with formula" of acute lung disease from the beginning of the study to the end of study.
Measure: Biochemical parameter of acute lung disease Time: 1 monthDescription: Variation of biochemical parameter "erythrocyte sedimentation rate" of acute lung disease from the beginning of the study to the end of study.
Measure: Biochemical parameter of acute lung disease Time: 1 monthDescription: Variation of biochemical parameter "blood gas analysis" of acute lung disease from the beginning of the study to the end of study.
Measure: Biochemical parameter of acute lung disease Time: 1 monthDescription: Variation of biochemical parameter "LDH" of acute lung disease from the beginning of the study to the end of study.
Measure: Biochemical parameter of acute lung disease Time: 1 monthDescription: The alteration of Dipeptilpeptidase 4 expression will be evaluated in the collected biological samples
Measure: Dipeptilpeptidase 4 expression in biological samples Time: 6 monthsDescription: Evaluation of inflammatory cytokines IL-2 and IL-7 in biological samples of treated patients and control group patients during infection.
Measure: Cytokine-inflammatory profile Time: 6 monthsDescription: Effect on glycemic variability by evaluating HbA1c levels.
Measure: Glycemic variability Time: 1 monthDescription: Effect on glycemic variability by evaluating the average daily blood glucose levels.
Measure: Glycemic variability Time: 1 monthDescription: Evaluation of the inflammatory cytokine granulocyte-colony stimulating factor in biological samples of treated patients and control group patients during infection.
Measure: Cytokine-inflammatory profile Time: 6 monthsDescription: Evaluation of the inflammatory cytokine interferon-γ inducible protein 10 in biological samples of treated patients and control group patients during infection.
Measure: Cytokine-inflammatory profile Time: 6 monthsDescription: Evaluation of the inflammatory cytokine monocyte chemoattractant protein 1 in biological samples of treated patients and control group patients during infection.
Measure: Cytokine-inflammatory profile Time: 6 monthsDescription: Evaluation of the inflammatory cytokine macrophage inflammatory protein 1-α in biological samples of treated patients and control group patients during infection.
Measure: Cytokine-inflammatory profile Time: 6 monthsDescription: Evaluation of the inflammatory cytokine tumour necrosis factor-α in biological samples of treated patients and control group patients during infection.
Measure: Cytokine-inflammatory profile Time: 6 monthsThe coronavirus disease 2019 (COVID-19) is an emerging pandemic in 2020 caused by a novel coronavirus named SARS-CoV2. Diabetes confers a significant additional risk for COVID-19 patients. Dipeptidyl peptidase 4 (DPP-4) is a transmembrane glycoprotein expressed ubiquitously in many tissues. In addition to its effect on glucose levels, DPP-4 has various effects on the immune system and several diseases, including lung diseases. This trial aims to assess the safety and efficacy of linagliptin, a DPP-4 inhibitor, in the treatment of COVID-19. The trial will be randomized without blinding, with one are treated by insulin only for glucose balance and the other by insulin and linagliptin. The trial will assess the effects of linagliptin on different measures of COVID-19 recovery.
Description: Clinical change is defined as 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19: 0 - No clinical or virological evidence of infection; 1 - No limitation of activities; 2 - Limitation of activities; 3 - Hospitalized, no oxygen therapy; 4 - Oxygen by mask or nasal prongs; 5 - Non-invasive ventilation or high-flow oxygen; 6 - Intubation and mechanical ventilation; 7 - Ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation; 8 - Death.
Measure: Time to clinical change Time: 28 daysDescription: Percent of patients with a 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19.
Measure: Percent of patients with clinical improvement. Time: 28 daysThe study design is observational, exploratory study consisting of two cohorts of COVID-19 patients admitted to the ICU and the medical ward, respectively. The primary outcome focusing on the effect of plasma glucose levels on cardiac function will be evaluated by repeated assessment of cardiac function by echocardiography and measurement of plasma glucose. Furthermore, blood coagulability will be evaluated to determine the importance of diabetes status and plasma glucose changes for whole blood coagulability at time of admission to the ICU and progression in coagulability abnormalities. In the medical ward cohort, two assessments will be performed separated by no more than 12 hours. In the ICU cohort, three assessments will be performed separated by no more than 6 hours. Ideally, 60 patients with COVID-19 will be included in the ICU cohort with a 1:1 distribution between patient with and without diabetes. Ideally, 40 patients with diabetes will be included in the cohort of patients admitted to medical ward (hospitalisation cohort). The primary hypothesis is that levels of plasma glucose have clinically significant impact on left ventricular systolic function in patients with COVID-19 admitted to the ICU. The secondary hypothesis is that the impact of plasma glucose on left ventricular systolic function is associated with glycaemic control prior to admission as measured by HbA1c.
Description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction (a pooled analysis of the hospitalisation cohort and ICU cohort)
Measure: Plasma glucose levels and left ventricular ejection fraction Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
Measure: Key secondary outcome: HbA1c, plasma glucose levels and left ventricular systolic function Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis (a pooled analysis of the hospitalisation cohort and ICU cohort)
Measure: Plasma glucose levels and strain analysis Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity (a pooled analysis of the hospitalisation cohort and ICU cohort)
Measure: Plasma glucose levels and mitral annular systolic velocity Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
Measure: Plasma glucose levels and left ventricular ejection fraction (sub-group analysis) Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
Measure: Plasma glucose levels and strain analysis (sub-group analysis) Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively
Measure: Plasma glucose levels and mitral annular systolic velocity (sub-group analysis) Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
Measure: HbA1c, Plasma glucose levels and strain analysis Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)
Measure: HbA1c, Plasma glucose levels and mitral annular systolic velocity Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).Description: Difference in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes at time of admission to the ICU (ICU cohort only)
Measure: Diabetes status and whole blood coagulability and fibrinolysis Time: At time of admission to the ICU (max. 24 hours after admission to the ICU)Description: Difference in change in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes treated at the ICU (ICU cohort only)
Measure: Diabetes status and change in whole blood coagulability and fibrinolysis during ICU stay Time: From first until last assessment during ICU stay (max. 24 hours).Description: The prognostic value of cardiac function and TEG on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death
Measure: Prognostic value of TEG analysis Time: From time of admission and until four weeks after admissionDescription: The prognostic value of cardiac function on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death
Measure: Prognostic value of cardiac function Time: From time of admission and until four weeks after admissionDescription: Difference in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)
Measure: Diabetes status and high-sensitivity troponins Time: At the time of admission to the ICU (max. 24 hours after admission to the ICU)Description: Difference in change in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)
Measure: Diabetes status and change high-sensitivity troponins Time: From first until last assessment during ICU stay (max. 24 hours)The strict rules applied in Italy during the recent COVID-19 pandemic, with the prohibition to attend any regular outdoor activity, are likely to influence the degree of metabolic control of patients with type 2 diabetes. The aim of this observational, prospective, single centre study was to evaluate the immediate impact of the lockdown rules on the metabolic profile of a cohort of patients with type 2 diabetes.
Description: Blood glucose was expressed in mg/dl and was determined by standard techniques.
Measure: Glucose Time: One week after the end of the lockdown periodDescription: HbA1c was expressed as percentage or mmol/l and was determined by standard techniques.
Measure: HbA1c Time: One week after the end of the lockdown periodDescription: Complete lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, Triglcerydes) were expressed in mg/dl or mmol/l and were determined by standard techniques.
Measure: Lipid profile Time: One week after the end of the lockdown periodThe purpose of this study is to evaluate whether Canakinumab has beneficial effects on patients with Type 2 diabetes mellitus and coronavirus disease 19 (COVID19).
Description: Treatment and placebo will be compared on the basis of the unmatched win-ratio approach of Pocock. When comparing two patients, the winner will be determined by the first component in which the two patients differ (4 weeks after randomization): longer survival time longer ventilation-free time longer ICU-free time shorter hospitalization time If there is no difference between treatment and Placebo: the win ratio is 1. If there is a difference between treatment and Placebo: the win ratio is not 1.
Measure: unmatched win ratio after treatment with canakinumab compared to Placebo (composite endpoint) Time: within 4 weeks after treatment with canakinumab or placeboDescription: Time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever comes first. "The seven-category ordinal scale consists of the following categories: not hospitalized with resumption of normal activities; not hospitalized, but unable to resume normal activities; hospitalized, not requiring supplemental oxygen; hospitalized, requiring supplemental oxygen; hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and death"
Measure: Time to clinical improvement Time: From randomization up to 4 weeksDescription: Death rate during the 4-week period after study treatment
Measure: Death rate Time: 4 weeksDescription: Admission to the intensive care unit from the medical ward during the 4-week period after study treatment
Measure: Admission to intensive care unit (ICU) Time: 4 weeksDescription: Secondary worsening of disease (i.e., development of Acute respiratory distress Syndrome (ARDS), increase of oxygen demand after 72h of treatment)
Measure: Secondary worsening of disease Time: 4 weeksDescription: Prolonged hospital stay > 3 weeks
Measure: Prolonged hospital stay Time: >3 weeksDescription: Ratio to baseline in the glycated hemoglobin
Measure: Change in ratio to baseline in the glycated hemoglobin Time: Baseline, Day 29 and Day 90Description: Ratio to baseline in the fasting glucose
Measure: Change in ratio to baseline in the fasting glucose Time: Baseline, Day 29Description: Ratio to baseline in the fasting insulin
Measure: Change in ratio to baseline in the fasting insulin Time: Baseline, Day 29Description: Ratio to baseline in the fasting c-peptide
Measure: Change in ratio to baseline in the fasting c-peptide Time: Baseline, Day 29Description: Ratio to baseline in the C-reactive protein (CRP)
Measure: Ratio to baseline in the C-reactive protein (CRP) Time: Baseline, Day 29 and Day 90Description: Ratio to baseline in the D-dimer
Measure: Change in ratio to baseline in the D-dimer Time: Baseline, Day 29Description: Ratio to baseline in the Natriuretic peptide (NTproBNP)
Measure: Change in ratio to baseline in the Natriuretic peptide (NTproBNP) Time: Baseline, Day 29 and Day 90Description: Ratio to baseline in the Glomerular Filtration Rate Renal (eGFR)
Measure: Change in ratio to baseline in the Glomerular Filtration Rate Renal (eGFR) Time: Baseline, Day 29 and Day 90Description: Type of antidiabetic treatment at Day 29
Measure: Type of antidiabetic treatment at Day 29 Time: Day 29Description: Number of antidiabetic treatment at Day 29
Measure: Number of antidiabetic treatment at Day 29 Time: Day 29Description: Type of antidiabetic treatment at three months
Measure: Type of antidiabetic treatment at three months Time: Month 3Description: Number of antidiabetic treatment at three months
Measure: Number of antidiabetic treatment at three months Time: Month 3The treatment with pioglitazone added to the standard treatment of patients with DM2 hospitalized for COVID-19 may produce a decrease in the number of patients who progress to a second phase of severe systemic inflammation.
Description: Number of patients receive pioglitazone treatment during their hospital stay who receive support with mechanical ventilation, enter the ICU and / or die.
Measure: Patients treated with pioglitazone, together with conventional treatment for COVID-19 infection, who during their admission evolve towards the need to receive support with mechanical ventilation, enter the ICU and / or die. Time: Through hospitalization period, an average of 10-20 days until hospital dischargeDescription: Proportion of patients who develop heart failure or adverse reaction associated with treatment.
Measure: Incidence of pioglitazone treatment-Emergent Adverse Events in patients with DM2 and symptomatic SARS-CoV-2 infection. Time: Everyday through hospitalization period, an average of 10-20 days until hospital dischargeDescription: Changes in this inflammation parameter: C-reactive protein (in mg/dl)
Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment. Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital dischargeDescription: Changes in this inflammation parameter: D-dimer (in μg/mL)
Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment. Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital dischargeDescription: Changes in this inflammation parameter: ferritin (in ng/mL)
Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment. Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital dischargeDescription: Changes in this inflammation parameter: creatine kinase (CK) (in mg/dL)
Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment. Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital dischargeDescription: Changes in this inflammation parameter: number of lymphocytes (in μL)
Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment. Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital dischargeThis pragmatic 3-arm randomized controlled trial is conducted within the primary health care setting. The trial evaluates the effectiveness of a personalized eHealth intervention based on a hip-worn accelerometer, smartphone application and cloud service (www.exced.com) with or without face-to-face and telephone counselling contacts on physical activity (PA) compared to usual care in increasing daily PA and reducing sedentary behavior (SB) among type 2 diabetes (T2D) patients.The duration of the intervention period is 6 months, after which there is a 6 month follow-up for evaluating the maintenance of anticipated intervention effects. The primary goal of the intervention is that the T2D patients increase their daily number of steps by replacing SB with low intensity PA. The secondary goal is to increase short bouts of moderate-to-vigorous PA according to personal goals. It is expected that the eHealth intervention complemented by individual counselling is the most effective in reaching the goals, and the eHealth intervention is more effective than usual care. Measurements are done at baseline, after the 6-month intervention, and after the 6-month follow-up. Participants' one-week PA and SB are measured with a hip-worn triaxial accelerometer and analyzed with validated algorithms. Cardiorespiratory fitness is assessed with a validated 6-minute walk test. Diabetes-related metabolic biomarkers (HbA1C, LDL-c, HDL-c, oxidized LDL and HDL lipids) and cardiovascular risk factors (blood pressure, BMI, waist circumference) are measured with standard laboratory methods. Quality of life is assessed by RAND-36 method. The interventions are evaluated with RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) method. Besides effectiveness, RE-AIM methods evaluates the target group reach and adherence; provider adoption; intervention fidelity; maintenance of the changes in PA and SB behavior, biomarkers and CVD risk factors; intervention transferability to clinical practice; adverse events; and patient and provider satisfaction. Unexpectedly, the COVID-19 pandemic in spring 2020 led to substantial restrictions in outdoors mobility of T2D patients and their access access to health care in Finland, facts that frustrated the planned implementation of the original intervention, related measurements and their scheduling. This means that not all planned measurements could be done at all or at the scheduled time point. Irrespective of the time of recruitment, all follow-up measurements are done from June to September 2020. Notwithstanding the COVID-19 pandemic annulled the original intervention, the collected data yet provides unique insights into measured physical activity, fitness and metabolic biomarkers of T2D patients before and during the COVID-19 pandemic and consequent restrictions.In addition, the data allows to evaluate the implementation of eHealth approach and face-to-face and telephone PA counselling contacts within the primary health care setting.
Description: Step count during one week is measured with a hip-worn accelerometer at baseline, 6 months, and 12 months
Measure: Change in total mean daily step count Time: At 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment.Description: Sedentary time and PA time at different intensity ranges are measured with a hip-worn accelerometer at baseline, 6 months and 12 months
Measure: Changes in total mean daily time of sedentary, low intensity PA and moderate-to-vigorous PA Time: at 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment.Description: Durations of moderate-to-vigorous PA bouts measured with a hip-worn accelerometer at baseline, 6 months and 12 months
Measure: Changes in the mean daily number of moderate-to-vigorous PA bouts lasting at least 1, 5 and 10 minutes. Time: at 6 and 12 months compared to baseline (0 months). N.B. Because of COVID-19, the schedule and contents of measurements may change individually depending on the time of recruitment.The COVID-19 pandemic has triggered extremely high hospitalization rates where mitigation strategies are urgently necessary to aid vulnerable Hispanic and Latino populations who are experiencing health disparities as well as high type 2 diabetes (T2D) prevalence with poor clinical outcomes when compared to non-Hispanic populations. The supplemental Dulce Digital-COVID Aware (DD-CA) intervention addresses specific barriers in diverse underserved Hispanic and Latino communities to improve glucose control and lower transmission of COVID-19 during a highly vulnerable period post hospitalization discharge, to reduce hospital readmission rates. This supplement will integrate COVID educational messaging with glucose management messaging within a low-cost, easily adoptable digital texting platform and offer critical information in a culturally and linguistically relevant manner to address specific barriers in diverse underserved communities.
Description: The Electronic Medical Record (EMR) will be used to identify readmissions during each patient's unique follow up period. Unadjusted between group differences will first be analyzed by comparing proportion of patients with any hospital readmissions within the 30-day period by a Fisher's exact test. Followup analyses will be conducted using multiple logistic regression models to account for gender, ethnicity, race, comorbid conditions including COVID-19, medication use, and baseline glycemic control, in addition to study arm, as fixed effects in predicting the primary outcome, rate of readmissions within 30-days. We do not anticipate missing data for covariates included in regression models since demographic data will be captured directly from the EMR, and baseline glycemic control (i.e. HbA1c at hospital admission) and COVID-19 diagnosis will be determined during the admission of study enrollment.
Measure: Readmission rate (30-days) Time: 30-daysDescription: Additional metrics of glycemic control will be captured for each study participant from the EMR including HbA1c at 90-days post-discharge. Unadjusted group mean differences in HbA1c will be assessed with a students t-test, followed by multiple linear regression analysis controlling for baseline HbA1c (at time of initial admission), as well as covariates including gender, ethnicity, race, comorbid conditions including COVID-19, and medication/steriod use, in addition to study arm, as fixed effects in predicting HbA1c at 90 days.
Measure: Glycosylated Hemoglobin (HbA1c) Time: Baseline, 90-daysDescription: Diabetes distress will be measured using the Diabetes Distress Scale (DDS); range 1-6, with higher scores indicating worse outcomes/greater diabetes-related emotional stress. The survey will be administered immediately post enrollment, prior to randomizing, and during the 90-day follow-up visit. Measures will be compared between groups by t-tests at each time point.
Measure: Diabetes Distress Scale Time: Baseline, 90-daysDescription: Research assistants will deliver the COVID-19 Patient Survey (PhenixToolkit) to each participant at their 90-day follow up to obtain their COVID-19 diagnosis status to determine whether any new infections occurred in the 90-day post-discharge time frame. Additional questions in the survey will be used for descriptive analyses to characterize infections. Differences in proportions of patients experiencing new infections per group (i.e. patients who were negative at discharge but had a self-reported positive test within 90 days) will be compared by Fisher's exact tests.
Measure: COVID-19 Patient Survey Time: 90-daysDescription: Summary of Diabetes Self-Care Activities (SDSCA; range 0-7, with higher scores indicating better outcomes/greater adherence to diabetes self-management behaviors) will be administered immediately post enrollment, prior to randomizing, and during the 90-day follow-up visit. Measures will be compared between groups by t-tests at each time point.
Measure: Summary of Diabetes Self-Care Activities Survey Time: Baseline, 90-daysDescription: Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 (range 0-100, with higher scores reflecting better outcomes/higher quality of life) will be administered immediately post enrollment, prior to randomizing, and during the 90-day follow-up visit. Measures will be compared between groups by t-tests at each time point.
Measure: PROMIS Quality of Life Scale Time: Baseline, 90-daysDescription: Knowledge, Attitudes and Practices Toward COVID-19 Survey (range 0-12, with higher scores reflecting better knowledge of COVID-19) will be administered immediately post enrollment, prior to randomizing, and during the 90-day follow-up visit. Measures will be compared between groups by t-tests at each time point.
Measure: Knowledge, Attitudes and Practice Toward COVID-19 Survey Time: Baseline, 90-daysDescription: Socio-Economic Status (SES), nativity, duration of US residence, Marital status, depressive symptoms and healthcare utilization will be measured immediately post enrollment, prior to randomizing.
Measure: Demographics Questionnaire Time: BaselineDescription: Exploratory analyses will be conducted similarly to our Primary Outcome. The EMR will be used to identify readmissions during each patient's unique follow up period. Unadjusted between group differences will first be analyzed by comparing proportion of patients with any hospital readmissions within the 90-day period by a Fisher's exact t-test. Followup analyses will be conducted using multiple logistic regression models to account for gender, ethnicity, race, comorbid conditions including COVID-19, medication use, and baseline glycemic control, in addition to study arm, as fixed effects in predicting the exploratory outcome, rate of readmissions within 90-days.
Measure: Readmission Rate (90-days) Time: 90-daysThe purpose of this study is to evaluate the efficacy and safety of metformin glycinate at dose of 620 mg twice per day plus standard treatment comparing to standard treatment alone (we will use placebo) of patients who have metabolic syndrome or type 2 diabetes, which have severe acute respiratory syndrome secondary to SARS-CoV-2.
Description: Assess differences in SARS-CoV-2 viral load between participants that receive placebo vs metformin glycinate
Measure: Viral Load Time: Day 0 to Day 8 or patient discharge dayDescription: Assess length of supplementary oxygen
Measure: Days of supplementary oxygen if apply Time: Day 0 to day 28 or patient discharge dayDescription: Assess length of mechanical ventilation
Measure: Days of supplementary mechanical ventilation if apply Time: Day 0 to day 28 or patient discharge dayDescription: Assess length of hospitalization
Measure: Days of Hospitalization Time: Day 0 to day 28 or patients discharge dayDescription: Assess the difference in the Proportion of participants with normalization of fever between participants that receive placebo vs the patients with metformin glycinate
Measure: Normalization of fever Time: Day 0 to day 28 or patient discharge dayDescription: Assess the difference in the Proportion of participants with normalization of oxygen saturation between participants that receive placebo vs the patients with metformin glycinate
Measure: Normalization of oxigen saturation Time: Day 0 to day 28 or patient discharge dayDescription: Assess the difference in the number of deaths between participants who received placebo versus the patients with metformin glycinate
Measure: Number of deaths Time: Day 0 to day 28 or patient discharge dayDescription: Evaluate if the level increase or decrease in serum creatinine compared to baseline. units: mg/dl
Measure: Change in Serum creatinine levels Time: Day 0 to day 28 or patients discharge dayDescription: Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Measure: Change in serum Troponin I Time: Day 0 to day 28 or patients discharge dayDescription: Evaluate if the level increase or decrease in serum aspartate aminotransferase compared to baseline. units: IU/l
Measure: Change in serum aspartate aminotransferase levels Time: Day 0 to day 28 or patients discharge dayDescription: Evaluate if the level increase or decrease in serum Creatine kinase-MB compared to baseline. Units: UI/l
Measure: Change in serum Creatine kinase-MB levels Time: Day 0 to day 28 or patients discharge dayDescription: Assess by incidence of grade 3, grade 4 and Serious adverse events
Measure: Incidence of adverse event Time: Day 0 to day 28 or patients discharge dayIn response to the COVID-19 pandemic, weight management programs and metabolic surgery have been deferred to contain the virus. Quarantine and social distancing negatively impact dietary, exercise and psychological health of obese individuals. The study aims to evaluate the impact of social distancing measures on post-metabolic surgery patients compare to non-surgical obese patients and discuss potential strategies for management post COVID-19.
Description: 1 question asked about participants weight in kg before the lockdown; 1 question asked participants about weight in kg during lockdown
Measure: Weight Time: June2020-July2020Description: Participants were asked 1 question on how well blood sugar was controlled before the lock down. An ordinal scale was used: Very Poor, Poor, Reasonable, Good, Very Good. Participants were asked 1 question on how well blood sugar was controlled during the lock down. An ordinal scale was used: Very Poor, Poor, Reasonable, Good, Very Good.
Measure: Blood Sugar Control Time: June2020-July 2020Description: Participants were asked how often medication was missed before the lockdown with1 question using an ordinal scale: Never, Once in a while, Sometime, Usually, All the Time. Participants were asked how often medication was missed during the lockdown with1 question using an ordinal scale: Never, Once in a while, Sometime, Usually, All the Time.
Measure: Medical Adherence Time: June 2020-July2020Description: Participants were asked on the level of stress before the lockdown using a Likert scale of 1-10; with 1=not stressful at all; 10= extremely stressful. Participants were asked level of stress were during the lockdown using a Likert scale of 1-10; with 1=not stressful at all; 10= extremely stressful.
Measure: Stress level Time: June 2020-July2020Description: Participants were asked frequency of exercise before the lockdown on a ordinal scale ranging from less than 1 time a week; Once a week; 2-3 times a week;4-5 times a week; More than 5 times a week. Participants were asked frequency of exercise during the lockdown on a ordinal scale ranging from less than 1 time a week; Once a week; 2-3 times a week;4-5 times a week; More than 5 times a week
Measure: Physical Activity Level Time: June2020-July 2020Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports