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Clinical Trial Details

Trial ID: L6833
Source ID: NCT04581447
Associated Drug: Metformin
Title: Extending Time Without Diabetes After Bariatric Surgery: a Trial Comparing the Metformin Addition or Not to Standard Care
Acronym: DiabOUT
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes|Bariatric Surgery|Metformin
Interventions: DRUG: Metformin|OTHER: Standard Care|DIETARY_SUPPLEMENT: Standardized meal
Outcome Measures: Primary: Proportion of patients with partial or complete T2D remission criteria, * Complete remission: HbA1c\<5.7% and no anti-diabetic medications (except metformin in the experimental group). * Partial remission: defined as prediabetes level of glycaemia i.e. HbA1c\<6.5% and no anti-diabetic medications (except metformin in the experimental group)., 3 years | Secondary: Proportion of patients with partial or complete T2D remission criteria, * Complete remission: HbA1c\<5.7% and no anti-diabetic medications (except metformin in the experimental group). * Partial remission: defined as prediabetes level of glycaemia i.e. HbA1c\<6.5% and no anti-diabetic medications (except metformin in the experimental group)., 1 and 2 years|Proportion of patients with strict complete T2D remission criteria, 3 years|Percentage of weight and BMI change, 1, 2 and 3 years|Fasting glycemia, Assessment of the level of cardio-metabolic parameters associated to T2D. Fasting glycemia and insulinemia will be combined to report HOMA-IR (homeostatic model assessment - insulin resistance)., 1, 2 and 3 years|Fasting insulinemia, Assessment of the level of cardio-metabolic parameters associated to T2D. Fasting glycemia and insulinemia will be combined to report HOMA-IR (homeostatic model assessment - insulin resistance)., 1, 2 and 3 years|Level of blood triglycerides, Assessment of the level of cardio-metabolic parameters associated to T2D., 1, 2 and 3 years|Level of blood HDL cholesterol, Assessment of the level of cardio-metabolic parameters associated to T2D., 1, 2 and 3 years|Blood pressure, Systolic and diastolic blood pressure., 1, 2 and 3 years|Level of blood albumin, Level of nutritional parameters associated with BS, 1, 2 and 3 years|Level of blood hemoglobin, Level of nutritional parameters associated with BS, 1, 2 and 3 years|Level of blood iron, Level of nutritional parameters associated with BS, 1, 2 and 3 years|Level of serum ferritin, Level of nutritional parameters associated with BS, 1, 2 and 3 years|Transferrin saturation percentage, Level of nutritional parameters associated with BS, 1, 2 and 3 years|Level of blood calcium, Level of nutritional parameters associated with BS, 1, 2 and 3 years|Level of blood vitamin D, Level of nutritional parameters associated with BS, 1, 2 and 3 years|Level of blood vitamin B1, Level of nutritional parameters associated with BS, 1, 2 and 3 years|Level of blood vitamin B9, Level of nutritional parameters associated with BS, 1, 2 and 3 years|Level of blood vitamin B12, Level of nutritional parameters associated with BS, 1, 2 and 3 years|Proportion of adverse effects in the intervention group compared to standard care, 3 years|Number of pills taken per patient, Adherence level assessment in the intervention group. Compliant patients are defined as taking at least 80% of assigned study pills in the intervention group., 1, 2 and 3 years|Level of plasmatic metformin, Adherence level assessment in the intervention group., 1, 2 and 3 years|Proportion of retinopathy events, 3 years|Proportion of nephropathy events, 3 years|Proportion of macroangiopathy events, 3 years|Numbers and proportions of patients with quality of life changes, assessed by EuroQol 5 Dimensions (EQ5D) auto-questionnaire, 1, 2 and 3 years|Clinical outcome at the end of the study, assessed by 5-year-Advanced-Diabetes Remission (5y-Ad-DiaRem) score, 3 years|Changes in fecal microbiota, 1 and 3 years|Glycemia, 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal|Insulinemia, 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal|Level of glucagon, 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal|Level of GLP-1, 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal|Level of GLP-2, 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal|Level of GIP, 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal|Level of oxyntomodulin, 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal|Level of PYY, 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal|Level of ghrelin, 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal|Level of glicentin, 6 months or 12 months; under fasting condition then 30 and 90 min after a standardized meal
Sponsor/Collaborators: Sponsor: Assistance Publique - Hôpitaux de Paris | Collaborators: Ministry of Health, France
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 126
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2021-01-07
Completion Date: 2026-11
Results First Posted:
Last Update Posted: 2023-06-08
Locations: CHU Amiens-Picardie - hôpital Nord, Amiens, France|AP-HP - hôpital Avicenne, Bobigny, France|CHU de Bordeaux - hôpital Haut-Lévêque, Bordeaux, France|AP-HP - hôpital Ambroise-Paré, Boulogne-Billancourt, France|AP-HP - hôpital Louis-Mourier, Colombes, France|Centre hospitalier intercommunal de Créteil, Créteil, France|CHU de Lille - hôpital Claude Huriez, Lille, France|AP-HM - hôpital de la Conception, Marseille, France|AP-HM - hôpital Nord, Marseille, France|AP-HP - hôpital européen Georges-Pompidou, Paris, 75015, France|AP-HP - hôpital Bichat-Claude Bernard, Paris, France|AP-HP - hôpital de la Pitié-Salpêtrière, Paris, France|Institut Mutualiste Montsouris, Paris, France|HCL - centre hospitalier Lyon-Sud, Pierre-Bénite, France|CH de Saint-Denis - hôpital Delafontaire, Saint-Denis, France|CHU de Toulouse - hôpital Larrey, Toulouse, France
URL: https://clinicaltrials.gov/show/NCT04581447