CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
Roux-en-Y Gastric Bypass plus total omentectomy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00545805
NCT00545805Phase 3Completed
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Effects of the Surgical Removal of Visceral Fat Tissue (Omentectomy) on Insulin Sensitivity in Grade III Obese Volunteers Subjected to Bariatric Surgery

University of Campinas, Brazil·interventional·Posted Oct 17, 2007·Updated Feb 20, 2013

In Brief

A Phase 3 clinical trial evaluating Roux-en-Y Gastric Bypass plus total omentectomy and Roux-en-Y Gastric Bypass for Insulin Resistance and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsulin Resistance, Obesity, Metabolic Syndrome X
CountriesBrazil
CollaboratorsFundação de Amparo à Pesquisa do Estado de São Paulo

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 17, 2007
Enrollment StartOct 1, 2005
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 18.7 years ago

Interventions

Roux-en-Y Gastric Bypass plus total omentectomyprocedure

Roux-en-Y Gastric Bypass plus total omentectomy

Roux-en-Y Gastric Bypassprocedure

Roux-en-Y Gastric Bypass without omentectomy