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Compares treatment options for Diabetes
Official title Extending Time Without Diabetes After Bariatric Surgery: a Trial Comparing the Metformin Addition or Not to Standard Care
ClinicalTrials.gov ID: NCT04581447
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as an once-daily, being studied as a potential treatment for diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Bobigny, France
- Bordeaux, France
- Boulogne-Billancourt, France
- Colombes, France
- Créteil, France
- Lille, France
- Marseille, France
- Paris, France
- Pierre-Bénite, France
- Saint-Denis, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Bobigny, France; Bordeaux, France; Boulogne-Billancourt, France; Colombes, France; Créteil, France and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.