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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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (13)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire Amiens - Picardie
Coordinator of this site? Confirm its status
AmiensFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Boulogne-BillancourtFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Colombes CedexFranceActive, not recruiting
Centre Hospitalier Intercommunal Créteil
Coordinator of this site? Confirm its status
CréteilFranceActive, not recruiting
Centre Hospitalier Universitaire De Lille
Coordinator of this site? Confirm its status
Lille CedexFranceActive, not recruiting
Centre Hospitalier Regional De Marseille
Coordinator of this site? Confirm its status
MarseilleFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
Coordinator of this site? Confirm its status
ParisFranceActive, not recruiting
Institut Mutualiste Montsouris
Coordinator of this site? Confirm its status
ParisFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Paris Cedex 13FranceActive, not recruiting
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Paris Cedex 18FranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
Coordinator of this site? Confirm its status
PessacFranceActive, not recruiting
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
Pierre-BéniteFranceActive, not recruiting
Centre Hospitalier Universitaire de Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.