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

Study acronym: REMISSION
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Mar 2025 to Mar 2027
    • Study completion date: Mar 2029 to Mar 2030
    • Site details revised
    v7
  2. Notable Primary completion date: Mar 2024 to Mar 2025
    • Study completion date: Mar 2024 to Mar 2029
    • Collaborators revised (2)
    v6
  3. Notable Phase: Phase 4 to Not applicable
    • Primary and study completion dates: Mar 2021 to Mar 2024
    v5
  4. Minor Site details revisedv4
  5. Minor Re-verified, no change to tracked fieldsv3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    • Collaborators revised (2)
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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 the metabolic recovery and quality of life in groups of diabetic patients treated with insulin, hypoglycemic agents or diet; 2) to establish the long term impact of the three surgeries on renal and cardiovascular functions in subgroup of patients with these conditions; 3) to compare metabolic impact of surgeries to those of best medical care for diabetes in a non-surgical control group. For most severely obese patients, lifestyle interventions, perhaps effective in inducing short-lived weight losses, are ineffective for long-term weight loss maintenance and durable metabolic recovery. The increasing popularity of obesity surgeries calls for a better understanding of the underlying mechanisms. This is especially true and urgent when considering that knowledge on the relative impact of each procedure (i.e. SG vs. RYGB and BPD-DS) in resolving T2D is still limited. Better knowledge on each of the procedures will allow stronger scientific rationale for selecting the right surgery for the right patient and improve care for the severely obese individual.
Trial Details
NCT Number NCT02390973
Lead Sponsor Laval University
Collaborators: Johnson & Johnson K.K. Medical Company, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Conditions
(from sponsor)
Bariatric Surgery Candidate, Diabetes
Related terms Diabetes Mellitus
Enrollment 408 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov