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

Primary Purpose

Bariatric Surgery Candidate, Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sleeve Gastrectomy
Roux-en-Y Gastric Bypass
Biliopancreatic Diversion with Duodenal Switch
Medical management
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery Candidate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Universitaire de Cardiologie et de Pneumologie de QuébecRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Sleeve gastrectomy

Roux-en-Y Gastric Bypass

Biliopancreatic Diversion

Control

Arm Description

the best medical management of their diabetes, non-surgical group

Outcomes

Primary Outcome Measures

Type 2 diabetes remission rate
percent of patient achieving type 2 diabetes remission in each groups

Secondary Outcome Measures

Change in microalbuminuria
Normalisation of A/C ratio after surgery
Change in retinopathy
Hypertension remission rate
percent of patient achieving hypertension remission in each groups
GERD remission rate
percent of patient achieving gastro-esophageal reflux disease resolution in each groups
Quality of life
quality of life after surgery eveluated with questionnaires
Sleep apnea remission rate
percent of patient achieving sleep apnea remission in each groups
weight loss
weight loss (kg)
Regression of liver disease
regression of liver disease documented by percutaneous liver biopsy after surgery
Dislipidemia remission
percent of patient achieving dislipidemia remission in each groups

Full Information

First Posted
February 16, 2015
Last Updated
February 17, 2021
Sponsor
Laval University
Collaborators
Johnson & Johnson Medical Products, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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1. Study Identification

Unique Protocol Identification Number
NCT02390973
Brief Title
Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
Acronym
REMISSION
Official Title
Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Johnson & Johnson Medical Products, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
408 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleeve gastrectomy
Arm Type
Active Comparator
Arm Title
Roux-en-Y Gastric Bypass
Arm Type
Active Comparator
Arm Title
Biliopancreatic Diversion
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Active Comparator
Arm Description
the best medical management of their diabetes, non-surgical group
Intervention Type
Procedure
Intervention Name(s)
Sleeve Gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y Gastric Bypass
Intervention Type
Procedure
Intervention Name(s)
Biliopancreatic Diversion with Duodenal Switch
Intervention Type
Other
Intervention Name(s)
Medical management
Primary Outcome Measure Information:
Title
Type 2 diabetes remission rate
Description
percent of patient achieving type 2 diabetes remission in each groups
Time Frame
from baseline up to 60 months
Secondary Outcome Measure Information:
Title
Change in microalbuminuria
Description
Normalisation of A/C ratio after surgery
Time Frame
from baseline up to 60 months
Title
Change in retinopathy
Time Frame
from baseline up to 60 months
Title
Hypertension remission rate
Description
percent of patient achieving hypertension remission in each groups
Time Frame
from baseline up yo 60 months
Title
GERD remission rate
Description
percent of patient achieving gastro-esophageal reflux disease resolution in each groups
Time Frame
from baseline up to 60 months
Title
Quality of life
Description
quality of life after surgery eveluated with questionnaires
Time Frame
from baseline up to 60 months
Title
Sleep apnea remission rate
Description
percent of patient achieving sleep apnea remission in each groups
Time Frame
from baseline up to 60 months
Title
weight loss
Description
weight loss (kg)
Time Frame
from baseline up to 60 months
Title
Regression of liver disease
Description
regression of liver disease documented by percutaneous liver biopsy after surgery
Time Frame
from baseline up to 60 months
Title
Dislipidemia remission
Description
percent of patient achieving dislipidemia remission in each groups
Time Frame
from baseline up to 60 months
Other Pre-specified Outcome Measures:
Title
short-term complications
Description
comparaison of intra-operative, post-operative and in-hospital complications between groups using clavien classification
Time Frame
baseline up to 4 month
Title
Long-term complications
Description
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
Time Frame
baseline up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Nadeau, MSc
Phone
418-656-8711
Ext
3490
Email
melanie.nadeau@criucpq.ulaval.ca
Facility Information:
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Québec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Nadeau, MSc
Phone
418-565-8711
Ext
3490
Email
melanie.nadeau@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Suzy Laroche
Phone
418-656-8711
Ext
4810
Email
suzy_laroche@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Laurent Biertho, MD
First Name & Middle Initial & Last Name & Degree
Andre Tchernof, PhD
First Name & Middle Initial & Last Name & Degree
François Dube, MD
First Name & Middle Initial & Last Name & Degree
Paul Poirier, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35739539
Citation
Bouchard-Mercier A, de Toro-Martin J, Nadeau M, Lescelleur O, Lebel S, Richard D, Biertho L, Tchernof A, Vohl MC. Molecular remodeling of adipose tissue is associated with metabolic recovery after weight loss surgery. J Transl Med. 2022 Jun 23;20(1):283. doi: 10.1186/s12967-022-03485-6.
Results Reference
derived
PubMed Identifier
31915151
Citation
Carreau AM, Noll C, Blondin DP, Frisch F, Nadeau M, Pelletier M, Phoenix S, Cunnane SC, Guerin B, Turcotte EE, Lebel S, Biertho L, Tchernof A, Carpentier AC. Bariatric Surgery Rapidly Decreases Cardiac Dietary Fatty Acid Partitioning and Hepatic Insulin Resistance Through Increased Intra-abdominal Adipose Tissue Storage and Reduced Spillover in Type 2 Diabetes. Diabetes. 2020 Apr;69(4):567-577. doi: 10.2337/db19-0773. Epub 2020 Jan 8.
Results Reference
derived

Learn more about this trial

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

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