Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
Recruiting
N/AInterventional Study
Bariatric Surgery CandidateDiabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
408 (estimated)
Sponsor
Laval University · Other
Who this trial is looking for
This trial is looking for patients with type 2 diabetes who are severely obese. Participants will undergo different types of bariatric surgery to see how these surgeries affect their diabetes and overall health over time.
Are You a Good Fit for This Trial?
You may be able to join if
I have type 2 diabetes
I have a BMI of 35 or higher
My HbA1c is 6.5% or higher
I can give my consent
You may not be able to join if
I am pregnant
I have had past esophageal or gastric surgery
I have severe abdominal pain or chronic digestive issues
I have a history of gastric or duodenal ulcers
I have severe liver or kidney disease
I have taken corticosteroids in the last month
I have a psychological problem affecting my understanding
I have abused drugs or alcohol in the last 12 months
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 ob…
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 Locations
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Eligibility Criteria
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 …
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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