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

  • STATUS
    Recruiting
  • End date
    May 27, 2026
  • participants needed
    350
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 27 May 2022
metformin
hemoglobin a1c

Summary

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.

Description

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.

Details
Condition Diabetes, Bariatric Surgery, Metformin
Treatment Standard Care, Metformin, Standardized meal
Clinical Study IdentifierNCT04581447
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

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
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