Bariatric Surgery Candidate, Diabetes
Conditions
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.
Interventions
PROCEDURESleeve Gastrectomy
PROCEDURERoux-en-Y Gastric Bypass
OTHERMedical management
Sponsors
Johnson & Johnson Medical Products
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Laval University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type 2 diabetes remission rate | from baseline up to 60 months | percent of patient achieving type 2 diabetes remission in each groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in microalbuminuria | from baseline up to 60 months | Normalisation of A/C ratio after surgery |
| Change in retinopathy | from baseline up to 60 months | — |
| Hypertension remission rate | from baseline up yo 60 months | percent of patient achieving hypertension remission in each groups |
| GERD remission rate | from baseline up to 60 months | percent of patient achieving gastro-esophageal reflux disease resolution in each groups |
| Quality of life | from baseline up to 60 months | quality of life after surgery eveluated with questionnaires |
| Regression of liver disease | from baseline up to 60 months | regression of liver disease documented by percutaneous liver biopsy after surgery |
| Dislipidemia remission | from baseline up to 60 months | percent of patient achieving dislipidemia remission in each groups |
| Sleep apnea remission rate | from baseline up to 60 months | percent of patient achieving sleep apnea remission in each groups |
| weight loss | from baseline up to 60 months | weight loss (kg) |
Other
| Measure | Time frame | Description |
|---|---|---|
| short-term complications | baseline up to 4 month | comparaison of intra-operative, post-operative and in-hospital complications between groups using clavien classification |
| Long-term complications | 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 |
Countries
Canada
Contacts
Primary ContactMelanie Nadeau, MSc
Outcome results
None listed