Surgical Removal of Visceral Fat Tissue (Omentectomy) Associated to Bariatric Surgery: Effects on Insulin Sensitivity

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

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-06-30

Brief Summary

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The intraabdominal fat is associated with insulin resistance, a condition that is in the basis of diabetes, metabolic syndrome and some cardiovascular diseases. It is not clear whether it is the origin of it or a surrogate marker only. We intend to compare the effects of bariatric surgery with versus without omentectomy in morbidly obese people intended to go through bariatric surgery, accessing insulin sensitivity by metabolic tests.

If the visceral fat is causative of insulin resistance, its surgical removal (omentectomy) might lead to improvement of insulin action, as seen in animal studies and in one study with morbidly obese human volunteers.

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Detailed Description

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In order to verify a potential additional benefit of omentectomy combined to Roux-en-Y silastic ring gastric bypass, insulin sensitivity will be studied by the gold-standard test, euglycemic-hyperinsulinemic clamp, since early postoperative follow-up (before significant weight variation), compared to a control group of bariatric surgery (same technique) alone. The variables will be analyzed in the post surgical evolution for correlation to metabolic changes: adiposity-related hormones and cytokines; lipid profile and other cardiovascular risk factors; molecular expression of biopsied subcutaneous adipocytes in vitro; anthropometrics; ultrasonography of abdominal subcutaneous and intra-abdominal fat depots and carotid intima-media thickness (preclinical atherosclerosis evaluation).

Conditions

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Insulin Resistance Obesity Metabolic Syndrome X

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OM group

Group Type EXPERIMENTAL

Roux-en-Y Gastric Bypass plus total omentectomy

Intervention Type PROCEDURE

Roux-en-Y Gastric Bypass plus total omentectomy

CT group

Control group

Group Type ACTIVE_COMPARATOR

Roux-en-Y Gastric Bypass

Intervention Type PROCEDURE

Roux-en-Y Gastric Bypass without omentectomy

Interventions

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Roux-en-Y Gastric Bypass plus total omentectomy

Intervention Type PROCEDURE

Roux-en-Y Gastric Bypass

Roux-en-Y Gastric Bypass without omentectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age between 21 and 50 years.
* Female sex.
* BMI between 40 and 50kg/m2.
* Metabolic syndrome (NCEP/ATP III criteria).

Exclusion Criteria

* Weight variation \>5% within 3 months prior to preoperative tests.
* Use of antidiabetic medications within 3 months prior to preoperative tests.
* HbA1c \>8%.
* Use of systemic corticosteroids for longer than 1 week within 3 months prior to preoperative tests.
* Hepatic cirrhosis, renal failure or any clinical condition (other than obesity) recognized as impairing insulin sensitivity.
* Present Smoking.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No