Actively Recruiting
Extending Time Without Diabetes After Bariatric Surgery: a Randomized Controlled Trial Comparing the Metformin Addition or Not to Standard Care
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-06-08
126
Participants Needed
16
Research Sites
17 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether adding metformin to standard care can extend the time people stay in diabetes remission after bariatric surgery. This study focuses on adults who had gastric bypass or sleeve gastrectomy surgery and previously had type 2 diabetes. The trial is randomized, controlled, open-label, and involves multiple centers to compare the effects of metformin addition on diabetes remission duration over three years. Participants are assigned to one of two groups: one group receives standard care plus metformin, starting at 850 mg once daily and increasing to twice daily after one month, while the other group receives standard care alone. Both groups receive regular lifestyle recommendations from nutrition and physical activity experts every six months. A subgroup of patients in the metformin group will undergo additional testing to study how metformin affects gut hormones. During the three-year study, participants will have follow-up visits every six months to monitor diabetes status, body weight, metabolic health, and quality of life. If diabetes returns, treatment with metformin or standard care stops, but participants remain in the study for further evaluation. Researchers will track a wide range of health measures including blood tests, diabetes remission status, nutritional status, medication adherence, and side effects to understand metformin's impact after bariatric surgery.
CONDITIONS
Brief Title
Extending Time Without Diabetes After Bariatric Surgery: a Trial Comparing the Metformin Addition or Not to Standard Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 70 years old
- Had gastric bypass or sleeve gastrectomy surgery 12 to 36 months before joining
- Previously diagnosed with type 2 diabetes treated with at least one anti-diabetic drug before surgery or had HbA1c 6.5% or higher before surgery
- Current HbA1c below 6.5% with no diabetes medications for the last three months
- Provided written consent to participate
You will not qualify if you...
- Diagnosis of type 1 diabetes
- Pregnancy or breastfeeding
- Estimated glomerular filtration rate below 44 ml/min
- Known intolerance or contraindications to metformin, including acute metabolic acidosis, severe infections, shock, recent heart attack, liver failure, or certain blood clotting disorders
- Alcohol use disorder
- Medical conditions or medications that may affect diabetes assessment, such as glucocorticoid treatment, renal transplant, Cushing's syndrome, acromegaly, or very high triglyceride levels
- Under legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 years
Participants receive either metformin plus standardized care or standardized care alone to extend diabetes remission after bariatric surgery.
Visits every 6 months for 3 years
Duration - Up to 3 years following treatment start
Participants continue monitoring after treatment ends to assess long-term outcomes and diabetes remission status.
Visits every 6 months for up to 3 years
Trial Site Locations
Total: 16 locations
1
CHU Amiens-Picardie - hôpital Nord
Amiens, France
Actively Recruiting
2
AP-HP - hôpital Avicenne
Bobigny, France
Withdrawn
3
CHU de Bordeaux - hôpital Haut-Lévêque
Bordeaux, France
Actively Recruiting
4
AP-HP - hôpital Ambroise-Paré
Boulogne-Billancourt, France
Actively Recruiting
5
AP-HP - hôpital Louis-Mourier
Colombes, France
Actively Recruiting
6
Centre hospitalier intercommunal de Créteil
Créteil, France
Actively Recruiting
7
CHU de Lille - hôpital Claude Huriez
Lille, France
Actively Recruiting
8
AP-HM - hôpital de la Conception
Marseille, France
Actively Recruiting
9
AP-HM - hôpital Nord
Marseille, France
Withdrawn
10
AP-HP - hôpital européen Georges-Pompidou
Paris, France, 75015
Actively Recruiting
11
AP-HP - hôpital Bichat-Claude Bernard
Paris, France
Actively Recruiting
12
AP-HP - hôpital de la Pitié-Salpêtrière
Paris, France
Actively Recruiting
13
Institut Mutualiste Montsouris
Paris, France
Actively Recruiting
14
HCL - centre hospitalier Lyon-Sud
Pierre-Bénite, France
Actively Recruiting
15
CH de Saint-Denis - hôpital Delafontaire
Saint-Denis, France
Not Yet Recruiting
16
CHU de Toulouse - hôpital Larrey
Toulouse, France
Actively Recruiting
Research Team
A
Aurélie GUIMFACK
Y
Yvann FRIGOUT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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