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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-01-31

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.

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Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gastric bypass bariatric surgery

Patients in this arm underwent Roux-en-Y gastric bypass bariatric surgery for the treatment of morbid obesity

Group Type ACTIVE_COMPARATOR

Bariatric surgery

Intervention Type PROCEDURE

Bariatric surgery

Sleeve gastrectomy bariatric surgery

Patients in this arm underwent sleeve gastrectomy bariatric surgery for the treatment of morbid obesity

Group Type ACTIVE_COMPARATOR

Bariatric surgery

Intervention Type PROCEDURE

Bariatric surgery

Interventions

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Bariatric surgery

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No