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NCT Number: NCT02390973

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

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location status: Recruiting

Location contact

Andre Tchernof, PhD

PRINCIPAL_INVESTIGATOR

François Dube, MD

SUB_INVESTIGATOR

Laurent Biertho, MD

PRINCIPAL_INVESTIGATOR

Melanie Nadeau, MSc

CONTACT

[email protected]

418-565-8711 ext. 3490

Paul Poirier, MD

SUB_INVESTIGATOR

Suzy Laroche

CONTACT

[email protected]

418-656-8711 ext. 4810

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleeve gastrectomy

Procedure

Roux-en-Y gastric bypass

Procedure

biliopancreatic diversion with duodenal switch

Procedure

Medical management

Other

Primary outcomes

  1. 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

  1. Change in microalbuminuria

    Time frame: from baseline up to 60 months

    Normalisation of A/C ratio after surgery

  2. Change in retinopathy

    Time frame: from baseline up to 60 months

  3. Hypertension remission rate

    Time frame: from baseline up yo 60 months

    percent of patient achieving hypertension remission in each groups

  4. GERD remission rate

    Time frame: from baseline up to 60 months

    percent of patient achieving gastro-esophageal reflux disease resolution in each groups

  5. Quality of life

    Time frame: from baseline up to 60 months

    quality of life after surgery eveluated with questionnaires

  6. Sleep apnea remission rate

    Time frame: from baseline up to 60 months

    percent of patient achieving sleep apnea remission in each groups

  7. weight loss

    Time frame: from baseline up to 60 months

    weight loss (kg)

  8. Regression of liver disease

    Time frame: from baseline up to 60 months

    regression of liver disease documented by percutaneous liver biopsy after surgery

  9. Dislipidemia remission

    Time frame: from baseline up to 60 months

    percent of patient achieving dislipidemia remission in each groups

Other outcomes

  1. short-term complications

    Time frame: baseline up to 4 month

    comparaison of intra-operative, post-operative and in-hospital complications between groups using clavien classification

  2. Long-term complications

    Time frame: baseline up to 60 months

    Vital status and long-term complications including cardiovascular events, micro- or macro-vascular complications, cancer, psychiatric events, bone fractures, operations, readmission related or unrelated to the surgery, changes in medical treatment will be compared between groups

Study contacts

Contact information is provided by the study sponsor or research team.

Melanie Nadeau, MSc

CONTACT

[email protected]

418-656-8711 ext. 3490

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
  • Johnson & Johnson Medical Products

Registry information

Acronym: REMISSION

Important dates

Study start
2015
Primary completion
2027
Study completion
2030
First posted
Mar 18, 2015
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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