NCT00545805

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

Effects of the Surgical Removal of Visceral Fat Tissue (Omentectomy) on Insulin Sensitivity in Grade III Obese Volunteers Subjected to Bariatric Surgery

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Insulin Resistance
• Obesity
• Metabolic Syndrome X

Interventions

Type	Name	Description
PROCEDURE	Roux-en-Y Gastric Bypass plus total omentectomy	Roux-en-Y Gastric Bypass plus total omentectomy
PROCEDURE	Roux-en-Y Gastric Bypass	Roux-en-Y Gastric Bypass without omentectomy

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-10-17
• Last updated: 2013-02-20

Locations

1 site across 1 country: Brazil