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

Diabetes Clinical Trial

— REMISSION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02390973
• Other study ID #: Remission
• Status: Recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: March 2024

Study information

• Verified date: February 2021
• Source: Laval University
• Contact: Melanie Nadeau, MSc
• Phone: 418-656-8711
• Email: melanie.nadeau[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 408
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Diabetes
• Diabetes Mellitus

Intervention

Procedure:
• Sleeve Gastrectomy

• Roux-en-Y Gastric Bypass

• Biliopancreatic Diversion with Duodenal Switch

Other:
• Medical management

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Québec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Johnson & Johnson Medical Products

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	short-term complications	comparaison of intra-operative, post-operative and in-hospital complications between groups using clavien classification	baseline up to 4 month
Other	Long-term complications	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	baseline up to 60 months
Primary	Type 2 diabetes remission rate	percent of patient achieving type 2 diabetes remission in each groups	from baseline up to 60 months
Secondary	Change in microalbuminuria	Normalisation of A/C ratio after surgery	from baseline up to 60 months
Secondary	Change in retinopathy		from baseline up to 60 months
Secondary	Hypertension remission rate	percent of patient achieving hypertension remission in each groups	from baseline up yo 60 months
Secondary	GERD remission rate	percent of patient achieving gastro-esophageal reflux disease resolution in each groups	from baseline up to 60 months
Secondary	Quality of life	quality of life after surgery eveluated with questionnaires	from baseline up to 60 months
Secondary	Sleep apnea remission rate	percent of patient achieving sleep apnea remission in each groups	from baseline up to 60 months
Secondary	weight loss	weight loss (kg)	from baseline up to 60 months
Secondary	Regression of liver disease	regression of liver disease documented by percutaneous liver biopsy after surgery	from baseline up to 60 months
Secondary	Dislipidemia remission	percent of patient achieving dislipidemia remission in each groups	from baseline up to 60 months