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Trial record 22 of 283 for:    Best Disease

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

Tracking Information
First Submitted Date  ICMJE February 16, 2015
First Posted Date  ICMJE March 18, 2015
Last Update Posted Date March 26, 2018
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2015)
Type 2 diabetes remission rate [ Time Frame: from baseline up to 60 months ]
percent of patient achieving type 2 diabetes remission in each groups
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02390973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2015)
  • Change in microalbuminuria [ Time Frame: from baseline up to 60 months ]
    Normalisation of A/C ratio after surgery
  • Change in retinopathy [ Time Frame: from baseline up to 60 months ]
  • Hypertension remission rate [ Time Frame: from baseline up yo 60 months ]
    percent of patient achieving hypertension remission in each groups
  • GERD remission rate [ Time Frame: from baseline up to 60 months ]
    percent of patient achieving gastro-esophageal reflux disease resolution in each groups
  • Quality of life [ Time Frame: from baseline up to 60 months ]
    quality of life after surgery eveluated with questionnaires
  • Sleep apnea remission rate [ Time Frame: from baseline up to 60 months ]
    percent of patient achieving sleep apnea remission in each groups
  • weight loss [ Time Frame: from baseline up to 60 months ]
    weight loss (kg)
  • Regression of liver disease [ Time Frame: from baseline up to 60 months ]
    regression of liver disease documented by percutaneous liver biopsy after surgery
  • Dislipidemia remission [ Time Frame: from baseline up to 60 months ]
    percent of patient achieving dislipidemia remission in each groups
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 11, 2015)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
Official Title  ICMJE Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bariatric Surgery Candidate
  • Diabetes
Intervention  ICMJE
  • Procedure: Sleeve Gastrectomy
  • Procedure: Roux-en-Y Gastric Bypass
  • Procedure: Biliopancreatic Diversion with Duodenal Switch
  • Other: Medical management
Study Arms  ICMJE
  • Active Comparator: Sleeve gastrectomy
    Intervention: Procedure: Sleeve Gastrectomy
  • Active Comparator: Roux-en-Y Gastric Bypass
    Intervention: Procedure: Roux-en-Y Gastric Bypass
  • Active Comparator: Biliopancreatic Diversion
    Intervention: Procedure: Biliopancreatic Diversion with Duodenal Switch
  • Active Comparator: Control
    the best medical management of their diabetes, non-surgical group
    Intervention: Other: Medical management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 11, 2015)
408
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Melanie Nadeau, MSc 418-656-8711 ext 3490 melanie.nadeau@criucpq.ulaval.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02390973
Other Study ID Numbers  ICMJE Remission
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laurent Biertho, Laval University
Study Sponsor  ICMJE Laval University
Collaborators  ICMJE
  • Johnson & Johnson Medical Products
  • Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Investigators  ICMJE Not Provided
PRS Account Laval University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP