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

Phase 2

Completed

• Conditions: Insulin Resistance; Obesity; Metabolic Syndrome X
• Interventions: Procedure: Roux-en-Y Gastric Bypass plus total omentectomy; Procedure: Roux-en-Y Gastric Bypass

• Registration Number: NCT00545805
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-17
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OM group	Roux-en-Y Gastric Bypass plus total omentectomy	-
CT group	Roux-en-Y Gastric Bypass	Control group

Primary Outcome Measures

Name	Time	Method
Increase of insulin sensitivity as measured by euglycemic-hyperinsulinemic clamp.	one month, six months and one year.

Secondary Outcome Measures

Name	Time	Method
increase of insulin secretion as measured by intravenous glucose tolerance test	one month, six months, one year
regression of carotid intima-media thickness	one month, six months, one year
Improvement of the insulin cell signalling in the subcutaneous adipose tissue.	one month, six months
increase of adipocytokines linked to greater insulin sensitivity and decrease of others linked to insulin resistance	one month, six months, one year

Trial Locations

Locations (1)

LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP); 🇧🇷 Campinas, SP, Brazil