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

February 17, 2013 updated by: Marcelo Miranda de Oliveira Lima, MD, PhD, University of Campinas, Brazil

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OM group
Procedure: Roux-en-Y Gastric Bypass plus total omentectomy
Roux-en-Y Gastric Bypass plus total omentectomy
Active Comparator: CT group
Control group
Procedure: Roux-en-Y Gastric Bypass
Roux-en-Y Gastric Bypass without omentectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase of insulin sensitivity as measured by euglycemic-hyperinsulinemic clamp.
Time Frame: one month, six months and one year.
one month, six months and one year.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Marcelo MO Lima, MD, University of Campinas (UNICAMP)
  • Principal Investigator: Bruno Geloneze, PhD, University of Campinas (UNICAMP)
  • Principal Investigator: José Carlos Pareja, PhD, University of Campinas (UNICAMP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (Estimate)

October 17, 2007

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 17, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIMED0001
  • FAPESP 05/58627-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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