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Clinical Trials/NCT02390973
NCT02390973
Recruiting
Not Applicable

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

Laval University1 site in 1 country408 target enrollmentMarch 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bariatric Surgery Candidate
Sponsor
Laval University
Enrollment
408
Locations
1
Primary Endpoint
Type 2 diabetes remission rate
Status
Recruiting
Last Updated
4 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2015
End Date
March 1, 2030
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laurent Biertho

Principal Investigator

Laval University

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Type 2 diabetes remission rate

Time Frame: from baseline up to 60 months

percent of patient achieving type 2 diabetes remission in each groups

Secondary Outcomes

  • GERD remission rate(from baseline up to 60 months)
  • Sleep apnea remission rate(from baseline up to 60 months)
  • weight loss(from baseline up to 60 months)
  • Dislipidemia remission(from baseline up to 60 months)
  • Change in microalbuminuria(from baseline up to 60 months)
  • Change in retinopathy(from baseline up to 60 months)
  • Hypertension remission rate(from baseline up yo 60 months)
  • Regression of liver disease(from baseline up to 60 months)
  • Quality of life(from baseline up to 60 months)

Study Sites (1)

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