Name (Synonyms) | Correlation | |
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drug464 | Linagliptin Wiki | 0.58 |
drug465 | Linagliptin 5 MG Wiki | 0.58 |
drug820 | Tele-interventions related to diabetes management and mental well-being Wiki | 0.58 |
drug427 | Insulin regimen Wiki | 0.58 |
Name (Synonyms) | Correlation | |
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D003920 | Diabetes Mellitus, NIH | 0.67 |
D008659 | Metabolic Diseases NIH | 0.58 |
D004700 | Endocrine System Diseases NIH | 0.58 |
D003922 | Diabetes Mellitus, Type 1 NIH | 0.58 |
D044882 | Glucose Metabolism Disorders NIH | 0.58 |
D012140 | Respiratory Tract Diseases NIH | 0.22 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.08 |
D018352 | Coronavirus Infections NIH | 0.06 |
Name (Synonyms) | Correlation |
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There are 3 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 ClĂnicas 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 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 days