RecruitingNot ApplicableNCT02390973

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


Sponsor

Laval University

Enrollment

408 participants

Start Date

Mar 1, 2015

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing weight-loss surgery (such as gastric bypass or sleeve gastrectomy) to the best available medical treatment to see which approach better controls blood sugar in the long term for people with both obesity and type 2 diabetes. **You may be eligible if...** - You have a body mass index (BMI) of 35 or higher - You have type 2 diabetes with blood sugar levels above the standard threshold - You are able to give informed consent **You may NOT be eligible if...** - You are pregnant - You have had previous stomach, esophagus, or weight-loss surgery - You have irritable bowel syndrome, unexplained vomiting, severe abdominal pain, or chronic diarrhea or constipation - You have a history of stomach or duodenal ulcers - You have severe kidney, liver, heart, or lung disease - You have taken steroid medications in the past month - You have a psychological condition affecting your ability to follow medical recommendations - You have used drugs or alcohol heavily in the last 12 months - You have inflammatory bowel disease (such as Crohn's or colitis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESleeve Gastrectomy
PROCEDURERoux-en-Y Gastric Bypass
PROCEDUREBiliopancreatic Diversion with Duodenal Switch
OTHERMedical management

Locations(1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

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NCT02390973


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