Name (Synonyms) | Correlation | |
---|---|---|
drug1001 | Glycaemic levels Wiki | 0.41 |
drug1346 | Linagliptin 5 MG Wiki | 0.41 |
drug2270 | Sitagliptin Wiki | 0.41 |
drug2082 | Respiratory physiotherapy Wiki | 0.41 |
drug2449 | Tele-interventions related to diabetes management and mental well-being Wiki | 0.41 |
drug1345 | Linagliptin Wiki | 0.41 |
drug1218 | Insulin regimen Wiki | 0.41 |
drug1795 | Peripheral blood draw Wiki | 0.29 |
drug2116 | Ruxolitinib Wiki | 0.14 |
Name (Synonyms) | Correlation | |
---|---|---|
D003920 | Diabetes Mellitus, NIH | 0.52 |
D008659 | Metabolic Diseases NIH | 0.41 |
D003922 | Diabetes Mellitus, Type 1 NIH | 0.41 |
D004700 | Endocrine System Diseases NIH | 0.41 |
D044882 | Glucose Metabolism Disorders NIH | 0.41 |
D012140 | Respiratory Tract Diseases NIH | 0.10 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
D018352 | Coronavirus Infections NIH | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0005978 | Type II diabetes mellitus HPO | 1.00 |
HP:0000819 | Diabetes mellitus HPO | 0.52 |
HP:0100651 | Type I diabetes mellitus HPO | 0.41 |
HP:0000818 | Abnormality of the endocrine system HPO | 0.41 |
There are 6 clinical trials
Sedentary behavior has been linked to cardiovascular morbidity and mortality, and is particularly common in older adults with type 2 diabetes. The purpose of this observational, mixed-methods study is to better understand the relationship between prolonged sedentary behavior and cardiovascular and metabolic health in older women.
Description: peak volume of oxygen consumption (VO2 peak) in ml/kg/min measured via graded exercise test
Measure: cardiorespiratory fitness Time: 8-12 minutesDescription: glucose infusion rate in mg/kg/min as measured via hyperinsulinemic-euglycemic clamp
Measure: insulin sensitivity Time: 3 hoursThe 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)