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

Not Applicable

Completed

• Conditions: Morbid Obesity

• Registration Number: NCT03851874
• Lead Sponsor: National and Kapodistrian University of Athens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-21
• Study First Posted: 2019-02-22
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in postprandial ghrelin responses	3, 6, and 12 months	Change in the cumulative postprandial response for ghrelin
Change in postprandial GLP-1 responses	3, 6, and 12 months	Change in the cumulative postprandial response for GLP-1
Change in postprandial PYY responses	3, 6, and 12 months	Change in the cumulative postprandial response for PYY

Secondary Outcome Measures

Name	Time	Method
Change in weight	3, 6, and 12 months	Change in weight (percentage of weight lost through each procedure)
Change in postprandial glycemia	3, 6, and 12 months	Change in the cumulative postprandial response for glucose
Change in postprandial insulinemia	3, 6, and 12 months	Change in the cumulative postprandial response for insulin
Change in postprandial triglyceridemia	3, 6, and 12 months	Change in the cumulative postprandial response for triglycerides