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

Primary Purpose

Insulin Resistance, Obesity, Metabolic Syndrome X

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Roux-en-Y Gastric Bypass plus total omentectomy
Roux-en-Y Gastric Bypass
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring Insulin resistance, Metabolic syndrome X, Obesity, Intra-Abdominal Fat, Omentum, Bariatric surgery, Glucose Clamp Technique, Intravenous Glucose Tolerance Test, Adiponectin, Cytokines

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OM group

CT group

Arm Description

Control group

Outcomes

Primary Outcome Measures

Increase of insulin sensitivity as measured by euglycemic-hyperinsulinemic clamp.

Secondary Outcome Measures

increase of insulin secretion as measured by intravenous glucose tolerance test
regression of carotid intima-media thickness
Improvement of the insulin cell signalling in the subcutaneous adipose tissue.
increase of adipocytokines linked to greater insulin sensitivity and decrease of others linked to insulin resistance

Full Information

First Posted
October 16, 2007
Last Updated
February 17, 2013
Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00545805
Brief Title
Surgical Removal of Visceral Fat Tissue (Omentectomy) Associated to Bariatric Surgery: Effects on Insulin Sensitivity
Official Title
Effects of the Surgical Removal of Visceral Fat Tissue (Omentectomy) on Insulin Sensitivity in Grade III Obese Volunteers Subjected to Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Obesity, Metabolic Syndrome X
Keywords
Insulin resistance, Metabolic syndrome X, Obesity, Intra-Abdominal Fat, Omentum, Bariatric surgery, Glucose Clamp Technique, Intravenous Glucose Tolerance Test, Adiponectin, Cytokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OM group
Arm Type
Experimental
Arm Title
CT group
Arm Type
Active Comparator
Arm Description
Control group
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y Gastric Bypass plus total omentectomy
Intervention Description
Roux-en-Y Gastric Bypass plus total omentectomy
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y Gastric Bypass
Intervention Description
Roux-en-Y Gastric Bypass without omentectomy
Primary Outcome Measure Information:
Title
Increase of insulin sensitivity as measured by euglycemic-hyperinsulinemic clamp.
Time Frame
one month, six months and one year.
Secondary Outcome Measure Information:
Title
increase of insulin secretion as measured by intravenous glucose tolerance test
Time Frame
one month, six months, one year
Title
regression of carotid intima-media thickness
Time Frame
one month, six months, one year
Title
Improvement of the insulin cell signalling in the subcutaneous adipose tissue.
Time Frame
one month, six months
Title
increase of adipocytokines linked to greater insulin sensitivity and decrease of others linked to insulin resistance
Time Frame
one month, six months, one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo MO Lima, MD
Organizational Affiliation
University of Campinas (UNICAMP)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno Geloneze, PhD
Organizational Affiliation
University of Campinas (UNICAMP)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Carlos Pareja, PhD
Organizational Affiliation
University of Campinas (UNICAMP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
City
Campinas
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
11850750
Citation
Thorne A, Lonnqvist F, Apelman J, Hellers G, Arner P. A pilot study of long-term effects of a novel obesity treatment: omentectomy in connection with adjustable gastric banding. Int J Obes Relat Metab Disord. 2002 Feb;26(2):193-9. doi: 10.1038/sj.ijo.0801871.
Results Reference
background
PubMed Identifier
9892227
Citation
Barzilai N, She L, Liu BQ, Vuguin P, Cohen P, Wang J, Rossetti L. Surgical removal of visceral fat reverses hepatic insulin resistance. Diabetes. 1999 Jan;48(1):94-8. doi: 10.2337/diabetes.48.1.94.
Results Reference
background
PubMed Identifier
12351432
Citation
Gabriely I, Ma XH, Yang XM, Atzmon G, Rajala MW, Berg AH, Scherer P, Rossetti L, Barzilai N. Removal of visceral fat prevents insulin resistance and glucose intolerance of aging: an adipokine-mediated process? Diabetes. 2002 Oct;51(10):2951-8. doi: 10.2337/diabetes.51.10.2951.
Results Reference
background
PubMed Identifier
17170226
Citation
Pitombo C, Araujo EP, De Souza CT, Pareja JC, Geloneze B, Velloso LA. Amelioration of diet-induced diabetes mellitus by removal of visceral fat. J Endocrinol. 2006 Dec;191(3):699-706. doi: 10.1677/joe.1.07069.
Results Reference
background
PubMed Identifier
20484482
Citation
Lima MM, Pareja JC, Alegre SM, Geloneze SR, Kahn SE, Astiarraga BD, Chaim EA, Geloneze B. Acute effect of roux-en-y gastric bypass on whole-body insulin sensitivity: a study with the euglycemic-hyperinsulinemic clamp. J Clin Endocrinol Metab. 2010 Aug;95(8):3871-5. doi: 10.1210/jc.2010-0085. Epub 2010 May 19.
Results Reference
result
PubMed Identifier
23404948
Citation
Lima MM, Pareja JC, Alegre SM, Geloneze SR, Kahn SE, Astiarraga BD, Chaim EA, Baracat J, Geloneze B. Visceral fat resection in humans: effect on insulin sensitivity, beta-cell function, adipokines, and inflammatory markers. Obesity (Silver Spring). 2013 Mar;21(3):E182-9. doi: 10.1002/oby.20030.
Results Reference
result

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

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