Extending Time Without Diabetes After Bariatric Surgery: a Trial Comparing the Metformin Addition or Not to Standard Care
DiabOUT
3 other identifiers
interventional
126
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes
Started Jan 2021
Longer than P75 for phase_3 diabetes
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedStudy Start
First participant enrolled
January 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
June 8, 2023
June 1, 2023
5.5 years
September 28, 2020
June 7, 2023
Conditions
Keywords
Outcome Measures
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).
3 years
Secondary Outcomes (37)
Proportion of patients with partial or complete T2D remission criteria
1 and 2 years
Proportion of patients with strict complete T2D remission criteria
3 years
Percentage of weight and BMI change
1, 2 and 3 years
Fasting glycemia
1, 2 and 3 years
Fasting insulinemia
1, 2 and 3 years
- +32 more secondary outcomes
Study Arms (2)
Metformin + Standard care
EXPERIMENTALThe pharmacological treatment (Metformin) will start at dose of 850 mg once daily and, at one month, increased to 850 mg twice daily. The dosage will be adjusted if necessary because of gastrointestinal symptoms and information on dose change during follow-up will be collected Adherence to study medications will be assessed by pills count and plasmatic dosage (Metformin group). All participants will receive standardized lifestyle recommendations regularly during all the time of the study Lifestyle recommendations will be provided by a nutritionist/diabetologist every 6 months at each study visit and reinforced by dedicated consultations with a dietician and a physical activity coach as usually performed in each center. This follow-up will be standardized for each center and applied equally to patients of both groups. Ancillary study measuring metformin-induced enterohormones secretion will be performed on a subgroup of 30 patients randomized in this arm.
Standard Care
OTHERAll participants will receive standardized lifestyle recommendations regularly during all the time of the study Lifestyle recommendations will be provided by a nutritionist/diabetologist every 6 months at each study visit and reinforced by dedicated consultations with a dietician and a physical activity coach as usually performed in each center. This follow-up will be standardized for each center and applied equally to patients of both groups. Ancillary study measuring metformin-induced enterohormones secretion will be performed on a subgroup of 30 patients randomized in this arm.
Interventions
Metformin will start at dose of 850 mg once daily and, at one month increased to 850 mg twice daily
Measurements of metformin-induced enterohormones secretion will be done after standardized meal test in a subgroup of patients (ancillary study)
Eligibility Criteria
You may qualify if:
- Adults 18-70 years old
- "ex-T2D" treated with at least one anti-diabetic drug before bariatric surgery or HbA1c ≥ 6.5 % before bariatric surgery
- Written consent
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
CHU Amiens-Picardie - hôpital Nord
Amiens, France
AP-HP - hôpital Avicenne
Bobigny, France
CHU de Bordeaux - hôpital Haut-Lévêque
Bordeaux, France
AP-HP - hôpital Ambroise-Paré
Boulogne-Billancourt, France
AP-HP - hôpital Louis-Mourier
Colombes, France
Centre hospitalier intercommunal de Créteil
Créteil, France
CHU de Lille - hôpital Claude Huriez
Lille, France
AP-HM - hôpital de la Conception
Marseille, France
AP-HM - hôpital Nord
Marseille, France
AP-HP - hôpital européen Georges-Pompidou
Paris, 75015, France
AP-HP - hôpital Bichat-Claude Bernard
Paris, France
AP-HP - hôpital de la Pitié-Salpêtrière
Paris, France
Institut Mutualiste Montsouris
Paris, France
HCL - centre hospitalier Lyon-Sud
Pierre-Bénite, France
CH de Saint-Denis - hôpital Delafontaire
Saint-Denis, France
CHU de Toulouse - hôpital Larrey
Toulouse, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claire CARETTE, MD
claire.carette@aphp.fr
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2020
First Posted
October 9, 2020
Study Start
January 7, 2021
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
June 8, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Two years after the last publication
- Access Criteria
- Data sharing must be accepted by the sponsor and the principal investigator (PI) based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Teams wishing obtain IPD must meet the sponsor and PI team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol could be shared for the purpose of a metaanalysis.