Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT02390973

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

Led by Laval University · Updated on 2025-12-08

408

Participants Needed

1

Research Sites

782 weeks

Total Duration

On this page

Sponsors

L

Laval University

Lead Sponsor

J

Johnson & Johnson Medical Products

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • BMI 65 35
  • Diagnosed with type 2 diabetes
  • HbA1c level 65 6.5% or fasting blood sugar 67 mmol/l or non-fasting blood sugar 6511 mmol/l
  • Able to give informed consent
Not Eligible

You will not qualify if you...

  • Currently pregnant
  • Previous esophageal, gastric, or bariatric surgery
  • Irritable bowel syndrome, unexplained vomiting, severe abdominal pain, chronic diarrhea or constipation
  • History of stomach or duodenal ulcers
  • Low albumin levels before surgery
  • Severe kidney, liver, heart, or lung disease
  • Corticosteroid use within the last month
  • Psychological issues affecting understanding or following medical advice
  • Drug use or alcohol abuse within the past 12 months
  • History of gastrointestinal inflammatory diseases

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

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Research Team

M

Melanie Nadeau, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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