NCT00545805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

3.7 years

First QC Date

October 16, 2007

Last Update Submit

February 17, 2013

Conditions

Insulin ResistanceObesityMetabolic Syndrome X

Keywords

Insulin resistanceMetabolic syndrome XObesityIntra-Abdominal FatOmentumBariatric surgeryGlucose Clamp TechniqueIntravenous Glucose Tolerance TestAdiponectinCytokines

Outcome Measures

Primary Outcomes (1)

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

    one month, six months and one year.

Secondary Outcomes (4)

  • 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

Study Arms (2)

OM group

EXPERIMENTAL
Procedure: Roux-en-Y Gastric Bypass plus total omentectomy

CT group

ACTIVE COMPARATOR

Control group

Procedure: Roux-en-Y Gastric Bypass

Interventions

Roux-en-Y Gastric Bypass plus total omentectomyPROCEDURE

Roux-en-Y Gastric Bypass plus total omentectomy

OM group
Roux-en-Y Gastric BypassPROCEDURE

Roux-en-Y Gastric Bypass without omentectomy

CT group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 21 and 50 years.
  • Female sex.
  • BMI between 40 and 50kg/m2.
  • Metabolic syndrome (NCEP/ATP III criteria).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Campinas, São Paulo, Brazil

Location

Related Publications (6)

  • 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.

    PMID: 11850750BACKGROUND

  • 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.

    PMID: 9892227BACKGROUND

  • 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.

    PMID: 12351432BACKGROUND

  • 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.

    PMID: 17170226BACKGROUND

  • 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.

    PMID: 20484482RESULT

  • 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.

    PMID: 23404948RESULT

MeSH Terms

Conditions

Insulin ResistanceObesityMetabolic Syndrome

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marcelo Miranda de Oliveira Lima, MD, PhD

Study Record Dates

First Submitted

October 16, 2007

First Posted

October 17, 2007

Study Start

October 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

BR(1)