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

ConditionsDiabetesBariatric SurgeryMetformin
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known type 1 diabetes

Pregnancy and breastfeeding

Estimated glomerular filtration rate<44 ml/min (MDRD)

Known intolerance to metformin

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metformin

    Drug

    Metformin will start at dose of 850 mg once daily and, at one month increased to 850 mg twice daily

  • Standard Care

    Other intervention

    Standard Care

  • Standardized meal

    Dietary supplement

    Measurements of metformin-induced enterohormones secretion will be done after standardized meal test in a subgroup of patients (ancillary study)

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Metformin + Standard careExperimental treatment 3 interventions
Group B: Standard CareOther 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients with partial or complete T2D remission criteria

* Complete remission: HbA1c\<5.7% and no anti-diabetic medications (except metformin in the experimental group). * Partial remission: defined as prediabetes level of glycaemia i.e. HbA1c\<6.5% and no anti-diabetic medications (except metformin in the experimental group).

Time frame
3 years

Secondary outcomes

1

Proportion of patients with partial or complete T2D remission criteria

* Complete remission: HbA1c\<5.7% and no anti-diabetic medications (except metformin in the experimental group). * Partial remission: defined as prediabetes level of glycaemia i.e. HbA1c\<6.5% and no anti-diabetic medications (except metformin in the experimental group).

Time frame
1 and 2 years
2

Proportion of patients with strict complete T2D remission criteria

Time frame
3 years
3

Percentage of weight and BMI change

Time frame
1, 2 and 3 years
4

Fasting glycemia

Assessment of the level of cardio-metabolic parameters associated to T2D. Fasting glycemia and insulinemia will be combined to report HOMA-IR (homeostatic model assessment - insulin resistance).

Time frame
1, 2 and 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Ministry of Health, France

Collaborator

Source ClinicalTrials.gov
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