Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT04581447 En recrutement IDF

Titre

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

Type

Interventional

Pathologie

Diabète

Phase

Phase 3

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

janvier 2021

Date de fin

novembre 2026

Dernière mise à jour

29 juin 2024

Résumé

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.

Détail

Voir le détail In addition to significant weight loss, several randomized control trials (RCTs) have demonstrated that bariatric surgery can reverse or at least improve type 2 diabetes (T2D). Despite the variability in study design and patient characteristics of these RCTs, there is a consistent favorable effect of surgery compared to medical treatment for weight loss, change in HbA1c, reduction in diabetes medications, remission of metabolic syndrome and improvement in quality of life. Diabetes remission rate is estimated from 15 to 45 % according to the 4 available RCT including the most used surgery (Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG)) with at least three to five years of follow-up. These results mean that more than half of patients with type 2 diabetes are still or newly diagnosed with diabetic after surgery and that extending time of diabetes remission after bariatric surgery is of major concern. No RCT has explored yet an intervention to extend diabetes remission. Apart from bariatric surgery, metformin is unequivocally recommended to treat both diabetes and pre-diabetes along with lifestyle interventions. Results of the Diabetes Prevention Program trial showed that metformin reduces diabetes incidence by 31% in obese patients with pre-diabetes. We hypothesized that metformin might extend the duration of diabetes remission after bariatric surgery. The study is a randomized, controlled, open-labeled, multicenter trial. Patients fulfilling the inclusion criteria and without any of the exclusion criteria will be randomized. Patients will receive: - Standardized care plus metformin treatment if randomized in the experimental group given for 3 years - Standardized care alone if randomized in the reference group Primary objective is 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. Secondary objectives are: - To assess the proportion of patients with T2D partial or complete remission with metformin compared to standard care in ex-T2D patients operated of BS, after 1 and 2 years of treatment. - To assess body weight and metabolic parameters in metformin group versus standard care. - To assess tolerance, nutritional status and adherence to metformin in intervention group versus standard care. - To assess micro and macroangiopathy at 3 years. - To assess quality of life changes from baseline at 1, 2 and 3 years. - To assess the accuracy of long term prediction score (i.e. prolonged remission assessed at the end of the study with the Ad-DiaRem score) - To explore gut contribution to metformin metabolic effect by: (i) gut microbiota differences (diversity, composition and function) between metformin treated and non-treated individuals and (ii) measurements of metformin-induced enterohormones secretion Patients are followed up every 6 months during 3 years in both arms. If diabetes is diagnosed during the follow-up (HbA1c > 6.5 %), the primary endpoint of the study is obtained meaning end of diabetes remission but patients will be still followed up to the end of protocol to monitor the secondary endpoints. When remission is over, the care defined by the protocol (ie metformin + standardized care or standardized care alone) should be stopped. In both groups, when remission is over, management of the disease has to be adapted according to physician's and patient's preference whatever the arm of randomization. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
AP-HP - Hôpital Ambroise Paré	CARETTE Claire	Active, sans recrutement	18/04/2025 07:56:35	Contacter
AP-HP - Hôpital Avicenne	CARETTE Claire	Active, sans recrutement	18/04/2025 07:56:35	Contacter
AP-HP - Hôpital Bichat	CARETTE Claire	Active, sans recrutement	18/04/2025 07:56:35	Contacter
AP-HP - Hôpital Europeen Georges Pompidou	CARETTE Claire	Active, sans recrutement	18/04/2025 07:56:35	Contacter
AP-HP - Hôpital La Pitié-Salpêtrière	CARETTE Claire	Active, sans recrutement	18/04/2025 07:56:35	Contacter
AP-HP - Hôpital Louis Mourier	CARETTE Claire	Active, sans recrutement	18/04/2025 07:56:35	Contacter
CHI DE CRETEIL	Sarah BATHAEI	Active, sans recrutement	29/03/2024 01:30:34	Contacter
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU de Lille - hôpital Claude Huriez - Lille - France	Hélène Verkindt, MD	En recrutement		Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HM - hôpital Nord - Marseille - France		Annulé		Contact (sur clinicalTrials)
AP-HP - hôpital de la Pitié-Salpêtrière - Paris - France	Judith Aron-Wisnewsky, MD	En recrutement		Contact (sur clinicalTrials)
Centre hospitalier intercommunal de Créteil - Créteil - France	Perle Sayedoff, MD	En recrutement		Contact (sur clinicalTrials)
CH de Saint-Denis - hôpital Delafontaire - Saint-Denis - France	Jean-Marc Catheline, MD	Recrutement non commencé		Contact (sur clinicalTrials)
CHU Amiens-Picardie - hôpital Nord - Amiens - France	Jean-Daniel Lalau, MD	En recrutement		Contact (sur clinicalTrials)
CHU de Bordeaux - hôpital Haut-Lévêque - Bordeaux - France	Maud Monsaingeon-Henry, MD	En recrutement		Contact (sur clinicalTrials)
CHU de Toulouse - hôpital Larrey - Toulouse - France	Patrick Ritz, MD	En recrutement		Contact (sur clinicalTrials)
HCL - centre hospitalier Lyon-Sud - Pierre-Bénite - France	Emmanuel Disse, MD	En recrutement		Contact (sur clinicalTrials)
Institut Mutualiste Montsouris - Paris - France	Guillaume Pourcher, MD	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT04581447 - Extending Time Without Diabetes After Bariatric Surgery: a Randomized Controlled Trial Comparing the Metformin Addition or Not to Standard Care (DiabOUT)

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