Comparison of Gastric Bypass and Sleeve Gastrectomy in Metabolic and Cardiovascular Indices

Study Overview
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Brief Summary
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Morbidly obese patients undergoing either Roux en Y gastric bypass or sleeve gastrectomy were examined preoperatively, 3, 6, and 12 months after surgery. On each occasion, anthropometric data were collected, resting metabolic rate was measured, and the patients underwent a panel of cardiovascular examinations (heart rate variability, baroreflex sensitivity, heart ultrasound). Following that, they consumed a test meal and completed visual analog scales for the subjective assessment of hunger and fullness every 30 minutes for 3 hours. At the same time points, blood samples were collected for the consequent measurement of glucose, insulin, lipids, and gastrointestinal hormones.

Official Title
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A Comparative Study of the Effects of Roux en Y Gastric Bypass and Sleeve Gastrectomy on Postprandial Gut Hormone Responses, Glycemia and Lipid Profile, Weight Loss, and Indices of Cardiovascular Risk

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Bariatric surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI >40 kg/m2 Age between 18 and 65 years Proven failure to lose weight through non-surgical interventions Exclusion Criteria: Serious and life threatening comorbidities (renal, cardiac, liver failure, or malignancy) Patients' inability to adhere to postsurgical instructions Alcohol or other substance abuse Concurrent psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gastric bypass bariatric surgery<br>Patients in this arm underwent Roux-en-Y gastric bypass bariatric surgery for the treatment of morbid obesity | Procedure: Bariatric surgery<br>* Bariatric surgery<br>|
| Active Comparator: Sleeve gastrectomy bariatric surgery<br>Patients in this arm underwent sleeve gastrectomy bariatric surgery for the treatment of morbid obesity | Procedure: Bariatric surgery<br>* Bariatric surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postprandial ghrelin responses | Change in the cumulative postprandial response for ghrelin | 3, 6, and 12 months | 
| Change in postprandial GLP-1 responses | Change in the cumulative postprandial response for GLP-1 | 3, 6, and 12 months | 
| Change in postprandial PYY responses | Change in the cumulative postprandial response for PYY | 3, 6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Change in weight (percentage of weight lost through each procedure) | 3, 6, and 12 months | 
| Change in postprandial glycemia | Change in the cumulative postprandial response for glucose | 3, 6, and 12 months | 
| Change in postprandial insulinemia | Change in the cumulative postprandial response for insulin | 3, 6, and 12 months | 
| Change in postprandial triglyceridemia | Change in the cumulative postprandial response for triglycerides | 3, 6, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery, gut peptides, weight loss, glycemia