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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03851874
Enrollment
28
Registered
2019-02-22
Start date
2011-10-31
Completion date
2014-01-31
Last updated
2019-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

Bariatric surgery, gut peptides, weight loss, glycemia

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.

Interventions

PROCEDUREBariatric surgery

Bariatric surgery

Sponsors

Beth Israel Deaconess Medical Center
CollaboratorOTHER
National and Kapodistrian University of Athens
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in postprandial ghrelin responses3, 6, and 12 monthsChange in the cumulative postprandial response for ghrelin
Change in postprandial PYY responses3, 6, and 12 monthsChange in the cumulative postprandial response for PYY
Change in postprandial GLP-1 responses3, 6, and 12 monthsChange in the cumulative postprandial response for GLP-1

Secondary

MeasureTime frameDescription
Change in postprandial glycemia3, 6, and 12 monthsChange in the cumulative postprandial response for glucose
Change in weight3, 6, and 12 monthsChange in weight (percentage of weight lost through each procedure)
Change in postprandial insulinemia3, 6, and 12 monthsChange in the cumulative postprandial response for insulin
Change in postprandial triglyceridemia3, 6, and 12 monthsChange in the cumulative postprandial response for triglycerides

Other

MeasureTime frameDescription
Change in heart rate variability3, 6, and 12 monthsChanges in heart rate variability
Change in Tei index3, 6, and 12 monthsChanges in echocardiographic Tei index
Change in baroreflex sensitivity3, 6, and 12 monthsChanges in baroreflex sensitivity
Change in aortic distensibility3, 6, and 12 monthsChanges in aortic distensibility

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026