Clinical trial

Extending Time Without Diabetes After Bariatric Surgery: a Randomized Controlled Trial Comparing the Metformin Addition or Not to Standard Care

Name

P170901J

Description

This study is a randomized trial that evaluates the effect of metformin addition or not to standard care on the duration of diabetes remission after bariatric surgery.

Trial arms

Trial start

2021-01-07

Estimated PCD

2026-07-01

Trial end

2026-11-01

Status

Recruiting

Phase

Early phase I

Treatment

Metformin

Metformin will start at dose of 850 mg once daily and, at one month increased to 850 mg twice daily

Arms:

Metformin + Standard care

Standard Care

Arms:

Metformin + Standard care, Standard Care

Standardized meal

Measurements of metformin-induced enterohormones secretion will be done after standardized meal test in a subgroup of patients (ancillary study)

Arms:

Metformin + Standard care, Standard Care

Size

126

Primary endpoint

Proportion of patients with partial or complete T2D remission criteria

3 years

Eligibility criteria

Inclusion Criteria: * Adults 18-70 years old * Having undergone gastric bypass or sleeve gastrectomy 12 to 36 +/-3 months before inclusion * "ex-T2D" treated with at least one anti-diabetic drug before bariatric surgery or HbA1c ≥ 6.5 % before bariatric surgery * HbA1C \< 6.5 % at inclusion with no anti-hyperglycemic medications for the last three months * Written consent Exclusion Criteria: * Known type 1 diabetes * Pregnancy and breastfeeding * Estimated glomerular filtration rate\<44 ml/min (MDRD) * Known intolerance to metformin * Known contraindication to metformin: * Acute metabolic acidosis * Acute affection which could lead to renal deterioration (ex: dehydration, serious infection, shock, intravascular administration of iodinated contrast agent within the last 48 hours) * Acute or chronic disease which could lead to a tissue hypoxia (ex : severe cardiac insufficiency, severe respiratory insufficiency, myocardial infarction within the last 3 months, shock) * Hepatocellular insufficiency * Prothrombin ratio ≤ 50% * SGOT or SGPT levels ≥ 10 times the upper limits of the normal range * Alcohol use disorder * Medications and medical conditions likely to confound the assessment of diabetes: * glucocorticoids treatment * renal graft * Cushing's syndrome * acromegaly * fasting plasma triglyceride \> 600 mg/dl despite treatment * Patient under legal protection

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 126, 'type': 'ESTIMATED'}}

Updated at

2023-06-08

1 organization

1 drug

3 indications

Organization

Assistance Publique - Hôpitaux de Paris

Drug

Indication

Indication

Indication