Surgical Removal of Visceral Fat Tissue (Omentectomy) Associated to Bariatric Surgery: Effects on Insulin Sensitivity
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Insulin Resistance Obesity Metabolic Syndrome X |
Procedure: Roux-en-Y Gastric Bypass plus total omentectomy Procedure: Roux-en-Y Gastric Bypass |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of the Surgical Removal of Visceral Fat Tissue (Omentectomy) on Insulin Sensitivity in Grade III Obese Volunteers Subjected to Bariatric Surgery |
- Increase of insulin sensitivity as measured by euglycemic-hyperinsulinemic clamp. [ Time Frame: one month, six months and one year. ] [ Designated as safety issue: No ]
- increase of insulin secretion as measured by intravenous glucose tolerance test [ Time Frame: one month, six months, one year ] [ Designated as safety issue: No ]
- regression of carotid intima-media thickness [ Time Frame: one month, six months, one year ] [ Designated as safety issue: No ]
- Improvement of the insulin cell signalling in the subcutaneous adipose tissue. [ Time Frame: one month, six months ] [ Designated as safety issue: No ]
- increase of adipocytokines linked to greater insulin sensitivity and decrease of others linked to insulin resistance [ Time Frame: one month, six months, one year ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | October 2005 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Brazil | |
| LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP) | |
| Campinas, SP, Brazil | |
| 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) |
More Information
Publications:
| Responsible Party: | Marcelo Miranda de Oliveira Lima, University of Campinas, Brazil |
| ClinicalTrials.gov Identifier: | NCT00545805 History of Changes |
| Other Study ID Numbers: | LIMED0001, FAPESP 05/58627-2 |
| Study First Received: | October 16, 2007 |
| Last Updated: | June 13, 2010 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Campinas, Brazil:
|
Insulin resistance Metabolic syndrome X Obesity Intra-Abdominal Fat Omentum |
Bariatric surgery Glucose Clamp Technique Intravenous Glucose Tolerance Test Adiponectin Cytokines |
Additional relevant MeSH terms:
|
Insulin Resistance Obesity Metabolic Syndrome X Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012
