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Clinical Trial Details

Trial ID: L6803
Source ID: NCT06826547
Associated Drug: Adjustment Of Insulin Doses Dar
Title: Optimization of Basal Insulin During Ramadan Fasting in Type 2 Diabetic Patients: Comparison Between DAR Recommendations and the Carbohydrate Fasting Test & Metabolic and Inflammatory Consequences
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2 Treated with Insulin|Fasting, Intermittent|Ramadan Fasting|Inflammatory Markers
Interventions: DRUG: Adjustment of insulin doses DAR|DRUG: Adjustment of insulin doses CFT
Outcome Measures: Primary: fructosamine levels, Fructosamine variation 15 days before \& the last week of Ramadan, up to 6 weeks|Interleukin-6 levels, variation during the fast of Ramadan 15 dayd before and at the Last week of Ramadan, up to 6 weeks|Hypoglycemia, Frequency of hypoglycemic episodes, up to one month|glycemic auto-monitoring, Percentage of blood glucose values meeting target levels during the month of Ramadan, up to one month|HbA1c levels, HbA1c variation before and after Ramadan 15 days before \& 2 months after Ramadan, up to 6 weeks|TNF-alfa levels, Variation during fasting Ramadan 15 days before and at the Last week of Ramadan, up to 6 weeks | Secondary: Body mass index, Body mass index variation : Before and at the Last week of Ramadan, up to 6 weeks|Quality of life of patients, Quality of life of patients assessed using the Medical Outcomes Study Short-Form General Health Survey (SF-12) questionnaire in its validated Tunisian dialect version. Before and at at the last week of Ramadan Higher score means a better quality of life., up to 6 weeks|waist circumference, variation of waist circumference: Before and at the Last week of Ramadan, up to 6 weeks|Blood pressure, Variation of blood pressure : Before and at the Last week of Ramadan, up to 6 weeks
Sponsor/Collaborators: Sponsor: University Tunis El Manar | Collaborators: Hopital La Rabta
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: EARLY_PHASE1
Enrollment: 100
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-02-15
Completion Date: 2025-05-30
Results First Posted:
Last Update Posted: 2025-02-14
Locations:
URL: https://clinicaltrials.gov/show/NCT06826547