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| Name | Class |
|---|---|
| Johnson & Johnson Medical Products | UNKNOWN |
| Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleeve gastrectomy | Active Comparator |
| |
| Roux-en-Y Gastric Bypass | Active Comparator |
| |
| Biliopancreatic Diversion | Active Comparator |
| |
| Control | Active Comparator | the best medical management of their diabetes, non-surgical group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleeve Gastrectomy | Procedure |
| ||
| Roux-en-Y Gastric Bypass |
| Measure | Description | Time Frame |
|---|---|---|
| Type 2 diabetes remission rate | percent of patient achieving type 2 diabetes remission in each groups | from baseline up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microalbuminuria | Normalisation of A/C ratio after surgery | from baseline up to 60 months |
| Change in retinopathy | from baseline up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| short-term complications | comparaison of intra-operative, post-operative and in-hospital complications between groups using clavien classification | baseline up to 4 month |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melanie Nadeau, MSc | Contact | 418-656-8711 | 3490 | melanie.nadeau@criucpq.ulaval.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire de Cardiologie et de Pneumologie de Québec | Recruiting | Québec | Quebec | G1V 4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35739539 | Derived | 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. | |
| 31915151 | Derived | 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. |
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|
| Biliopancreatic Diversion with Duodenal Switch | Procedure |
|
| Medical management | Other |
|
| Hypertension remission rate | percent of patient achieving hypertension remission in each groups | from baseline up yo 60 months |
| GERD remission rate | percent of patient achieving gastro-esophageal reflux disease resolution in each groups | from baseline up to 60 months |
| Quality of life | quality of life after surgery eveluated with questionnaires | from baseline up to 60 months |
| Sleep apnea remission rate | percent of patient achieving sleep apnea remission in each groups | from baseline up to 60 months |
| weight loss | weight loss (kg) | from baseline up to 60 months |
| Regression of liver disease | regression of liver disease documented by percutaneous liver biopsy after surgery | from baseline up to 60 months |
| Dislipidemia remission | percent of patient achieving dislipidemia remission in each groups | from baseline up to 60 months |
| baseline up to 60 months |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| D015904 | Biliopancreatic Diversion |
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D005763 | Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
| D001662 | Biliary Tract Surgical Procedures |
| D020399 | Practice Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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