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

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ClinicalTrials.gov Identifier: NCT02390973
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : March 26, 2018
Sponsor:
Collaborators:
Johnson & Johnson Medical Products
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Information provided by (Responsible Party):
Laurent Biertho, Laval University

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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Diabetes Procedure: Sleeve Gastrectomy Procedure: Roux-en-Y Gastric Bypass Procedure: Biliopancreatic Diversion with Duodenal Switch Other: Medical management Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 408 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
Study Start Date : March 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sleeve gastrectomy Procedure: Sleeve Gastrectomy
Active Comparator: Roux-en-Y Gastric Bypass Procedure: Roux-en-Y Gastric Bypass
Active Comparator: Biliopancreatic Diversion Procedure: Biliopancreatic Diversion with Duodenal Switch
Active Comparator: Control
the best medical management of their diabetes, non-surgical group
Other: Medical management



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390973


Contacts
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Contact: Melanie Nadeau, MSc 418-656-8711 ext 3490 melanie.nadeau@criucpq.ulaval.ca

Locations
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Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec Recruiting
Québec, Canada, G1V 4G5
Contact: Melanie Nadeau, MSc    418-565-8711 ext 3490    melanie.nadeau@criucpq.ulaval.ca   
Contact: Suzy Laroche    418-656-8711 ext 4810    suzy_laroche@ssss.gouv.qc.ca   
Principal Investigator: Laurent Biertho, MD         
Principal Investigator: Andre Tchernof, PhD         
Sub-Investigator: François Dube, MD         
Sub-Investigator: Paul Poirier, MD         
Sponsors and Collaborators
Laval University
Johnson & Johnson Medical Products
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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Responsible Party: Laurent Biertho, Principal Investigator, Laval University
ClinicalTrials.gov Identifier: NCT02390973     History of Changes
Other Study ID Numbers: Remission
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases