Bariatric Surgery CandidateREMISSIONNCT02390973
Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
A study testing Sleeve Gastrectomy, Roux-en-Y Gastric Bypass and Biliopancreatic Diversion with Duodenal Switch in people with Bariatric Surgery Candidate and Diabetes, run by Laval University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate, Diabetes
- What is being tested?
- Sleeve Gastrectomy, Roux-en-Y Gastric Bypass and Biliopancreatic Diversion with Duodenal Switch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI ≥ 35
- type 2 diabetes
- HbA1c ≥ 6,5 % or fasting glycemia ≥7mmol/l or non-fasting glycemia ≥11mmol/l
- able to consent
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5
Melanie Nadeau, MSc, 418-565-8711 ext. 3490, melanie.nadeau@criucpq.ulaval.ca
Suzy Laroche, 418-656-8711 ext. 4810, suzy_laroche@ssss.gouv.qc.ca
About this study
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.
- Conditions
- Bariatric Surgery Candidate, Diabetes
- Being tested
- Sleeve Gastrectomy, Roux-en-Y Gastric Bypass, Biliopancreatic Diversion with Duodenal Switch, Medical management
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve GastrectomyProcedure or surgery
Roux-en-Y Gastric BypassProcedure or surgery
Biliopancreatic Diversion with Duodenal SwitchProcedure or surgery
Medical managementOther
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy | Active comparator | Not described Receives: Procedure: Sleeve Gastrectomy |
| Roux-en-Y Gastric Bypass | Active comparator | Not described Receives: Procedure: Roux-en-Y Gastric Bypass |
| Biliopancreatic Diversion | Active comparator | Not described Receives: Procedure: Biliopancreatic Diversion with Duodenal Switch |
| Control | Active comparator | the best medical management of their diabetes, non-surgical group Receives: Other: Medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 diabetes remission rate
percent of patient achieving type 2 diabetes remission in each groups
Measured: from baseline up to 60 months
Secondary outcomes (9)
Change in microalbuminuria
Normalisation of A/C ratio after surgery
Measured: from baseline up to 60 months
Change in retinopathy
Measured: from baseline up to 60 months
Hypertension remission rate
percent of patient achieving hypertension remission in each groups
Measured: from baseline up yo 60 months
GERD remission rate
percent of patient achieving gastro-esophageal reflux disease resolution in each groups
Measured: from baseline up to 60 months
Quality of life
quality of life after surgery eveluated with questionnaires
Measured: from baseline up to 60 months
Sleep apnea remission rate
percent of patient achieving sleep apnea remission in each groups
Measured: from baseline up to 60 months
weight loss
weight loss (kg)
Measured: from baseline up to 60 months
Regression of liver disease
regression of liver disease documented by percutaneous liver biopsy after surgery
Measured: from baseline up to 60 months
Dislipidemia remission
percent of patient achieving dislipidemia remission in each groups
Measured: from baseline up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2027 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson K.K. Medical Company, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Responsible party
- Principal investigator, Laurent Biertho, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390973
- Sponsor's protocol ID
- Remission
- Acronym
- REMISSION
- Status last verified
- Oct 2025
- First submitted
- 16 Feb 2015
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35739539Carreau 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.
PubMed 31915151
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)
- ClinicalTrials.gov ID
- NCT02390973
- Acronym / sponsor ID
- REMISSION / Remission
- Conditions
- Bariatric Surgery Candidate, Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Johnson & Johnson K.K. Medical Company, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study start
- Mar 2015
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Medical managementthe best medical management of their diabetes, non-surgical group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI ≥ 35
- type 2 diabetes
- HbA1c ≥ 6,5 % or fasting glycemia ≥7mmol/l or non-fasting glycemia ≥11mmol/l
- able to consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeve Gastrectomy | Procedure or surgery | Sleeve gastrectomy |
| Roux-en-Y Gastric Bypass | Procedure or surgery | Roux-en-Y Gastric Bypass |
| Biliopancreatic Diversion with Duodenal Switch | Procedure or surgery | Biliopancreatic Diversion |
| Medical management | Other | Control |
Primary outcome
Type 2 diabetes remission rate
Time frame: from baseline up to 60 months
percent of patient achieving type 2 diabetes remission in each groups
9 secondary outcomes
Change in microalbuminuria
Time frame: from baseline up to 60 months
Change in retinopathy
Time frame: from baseline up to 60 months
Hypertension remission rate
Time frame: from baseline up yo 60 months
GERD remission rate
Time frame: from baseline up to 60 months
Quality of life
Time frame: from baseline up to 60 months
Sleep apnea remission rate
Time frame: from baseline up to 60 months
weight loss
Time frame: from baseline up to 60 months
Regression of liver disease
Time frame: from baseline up to 60 months
Dislipidemia remission
Time frame: from baseline up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Derived from this study: PubMed 35739539Bouchard-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.
- Derived from this study: PubMed 31915151Carreau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve Gastrectomy, Roux-en-Y Gastric Bypass and Biliopancreatic Diversion with Duodenal Switch in people with Bariatric Surgery Candidate and Diabetes, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie Nadeau, MSc (418-656-8711 ext. 3490, melanie.nadeau@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type 2 diabetes remission rate (time frame: from baseline up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02390973, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.