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Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)

RecruitingNAAges 18 Years - 60 YearsAllLaval University
NCT02390973 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Bariatric surgery procedures induce weight loss through restriction and/or malabsorption. The mechanisms underlying type 2 diabetes remission and others metabolic improvements after Roux-en-Y Gastric Bypass (RYGB), sleeve gastrectomy (SG) or biliopancreatic diversion with duodenal switch (BPD-DS) have not yet been formally studied. The investigators propose a longitudinal study with the overall objective of measuring the long-term impact of these three bariatric surgeries (RYGB, SG, BPD-DS) on metabolic, renal and cardiovascular fate in patients with type 2 diabetes. The investigators overall hypothesis is that some bariatric procedures generate hitherto unrecognized effects on many disease-related outcomes, which greatly contributes to their beneficial impact in diabetic patients. The investigators propose 3 specific aims: 1) to establish the long term effect of the three surgeries on t

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📋 Eligibility rules (as published)
Inclusion Criteria: * BMI ≥ 35 * type 2 diabetes * HbA1c ≥ 6,5 % or fasting glycemia ≥7mmol/l or non-fasting glycemia ≥11mmol/l * able to consent Exclusion Criteria: * pregnancy * past esophageal, gastric or bariatric surgery * irritable bowel, unexplained intermittent vomiting, severe abdominal pain, chronic diarrhea or constipation * history of gastric or duodenal ulcers * pre-operatory hypoalbuminemy * history of renal, hepatic, cardiac or pulmonary severe disease * taken of corticosteroid in the last month * evidence of psycological problem that may affect the capacity to understand the project and to comply with the medical recommandations * history of drug use or alcool abuse in the last 12 months * history of gastro-intestinal inflammatory diseases
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What it tests

  • Sleeve Gastrectomy
  • Roux-en-Y Gastric Bypass
  • Biliopancreatic Diversion with Duodenal Switch
  • Medical management
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Where

1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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