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Completed

NCT Number: NCT00545805

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

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.

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Key information

Conditions

Insulin Resistance Body Weight Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Campinas, São Paulo, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Roux-en-Y Gastric Bypass plus total omentectomy

Procedure

Roux-en-Y Gastric Bypass plus total omentectomy

Roux-en-Y gastric bypass

Procedure

Roux-en-Y Gastric Bypass without omentectomy

Primary outcomes

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

    Time frame: one month, six months and one year.

Secondary outcomes

  1. increase of insulin secretion as measured by intravenous glucose tolerance test

    Time frame: one month, six months, one year

  2. regression of carotid intima-media thickness

    Time frame: one month, six months, one year

  3. Improvement of the insulin cell signalling in the subcutaneous adipose tissue.

    Time frame: one month, six months

  4. increase of adipocytokines linked to greater insulin sensitivity and decrease of others linked to insulin resistance

    Time frame: one month, six months, one year

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Oct 17, 2007
Registry last updated
Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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