NCT02390973

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for not_applicable

Timeline
47mo left

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Mar 2015Mar 2030

First Submitted

Initial submission to the registry

February 16, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

December 8, 2025

Status Verified

October 1, 2025

Enrollment Period

12 years

First QC Date

February 16, 2015

Last Update Submit

December 1, 2025

Conditions

Bariatric Surgery CandidateDiabetes

Outcome Measures

Primary Outcomes (1)

  • Type 2 diabetes remission rate

    percent of patient achieving type 2 diabetes remission in each groups

    from baseline up to 60 months

Secondary Outcomes (9)

  • Change in microalbuminuria

    from baseline up to 60 months

  • Change in retinopathy

    from baseline up to 60 months

  • Hypertension remission rate

    from baseline up yo 60 months

  • GERD remission rate

    from baseline up to 60 months

  • Quality of life

    from baseline up to 60 months

  • +4 more secondary outcomes

Other Outcomes (2)

  • short-term complications

    baseline up to 4 month

  • Long-term complications

    baseline up to 60 months

Study Arms (4)

Sleeve gastrectomy

ACTIVE COMPARATOR
Procedure: Sleeve Gastrectomy

Roux-en-Y Gastric Bypass

ACTIVE COMPARATOR
Procedure: Roux-en-Y Gastric Bypass

Biliopancreatic Diversion

ACTIVE COMPARATOR
Procedure: Biliopancreatic Diversion with Duodenal Switch

Control

ACTIVE COMPARATOR

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

Other: Medical management

Interventions

Sleeve GastrectomyPROCEDURE
Sleeve gastrectomy
Roux-en-Y Gastric BypassPROCEDURE
Roux-en-Y Gastric Bypass
Biliopancreatic Diversion with Duodenal SwitchPROCEDURE
Biliopancreatic Diversion
Medical managementOTHER
Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI ≥ 35
  • type 2 diabetes
  • HbA1c ≥ 6,5 % or fasting glycemia ≥7mmol/l or non-fasting glycemia ≥11mmol/l
  • able to consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35739539DERIVED

  • 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.

    PMID: 31915151DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Gastric BypassBiliopancreatic DiversionPractice Management, Medical

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical ProceduresBiliary Tract Surgical ProceduresPractice ManagementProfessional PracticeOrganization and AdministrationHealth Services Administration

Central Study Contacts

Melanie Nadeau, MSc

CONTACT

418-656-8711melanie.nadeau@criucpq.ulaval.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2015

First Posted

March 18, 2015

Study Start

March 1, 2015

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2030

Last Updated

December 8, 2025

Record last verified: 2025-10

Locations

CA(1)