NCT04581447Active, not recruitingPhase 3
Study comparing a metformin treatment to standard care to extend time without diabetes after bariatric surgery
DIABOUT - Extending time without diabetes after bariatric surgery: a randomized controlled trial comparing the metformin addition or not to standard care
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 May 2026
Brief summary (registry, in English)
To demonstrate that metformin increases the proportion of patients with T2D remission compared to standard care among ex-T2D patients operated of BS, after a 3-year period of treatment.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 16 Jul 2024
- Start date
- 7 Jan 2021
- Lead sponsor
- Assistance Publique Hopitaux De Paris
- Diseases
- Type 2 diabetes
- NCT number
- NCT04581447
- EU CT number
- 2024-516409-22-00
- EudraCT number
- 2019-000312-28
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 126
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known type 1 diabetes
Lab values
- Known contraindication to metformin: o Acute metabolic acidosis o Acute affection which could lead to renal deterioration (ex: dehydration, serious infection, shock, intravascular administration of iodinated contrast agent within the last 48 hours) o 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) o Hepatocellular insufficiency o Prothrombin ratio ≤ 50% o SGOT or SGPT levels ≥ 10 times the upper limits of the normal range o Alcohol use disorder
- Medications and medical conditions likely to confound the assessment of diabetes: o glucocorticoids treatment o renal graft o Cushing’s syndrome o acromegaly o fasting plasma triglyceride > 600 mg/dl despite treatment
Other
- Pregnancy and breastfeeding
- Estimated glomerular filtration rate ≤44 ml/min (MDRD)
- Known intolerance to metformin
- Patient under legal protection
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Amiens - Picardie Coordinator of this site? Confirm its status | Amiens | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Colombes Cedex | France | Active, not recruiting |
| Centre Hospitalier Intercommunal Créteil Coordinator of this site? Confirm its status | Créteil | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Institut Mutualiste Montsouris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.