Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome

Morbid Obesity Clinical Trial

Official title:

A Prospective, Longitudinal Multicenter, Nontreatment, Exploratory Biomarker Study of Metabolic Syndrome in Subjects Undergoing Laparoscopic Roux-En-Y Gastric Bypass Bariatric Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00283374
• Other study ID #: 9804Z1-900
• Status: Terminated
• Phase: N/A
• First received: January 25, 2006
• Last updated: May 17, 2006
• Start date: October 2005

Study information

• Verified date: May 2006
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardEuropean Union: European Medicines Agency
• Study type: Observational

Clinical Trial Summary

Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its definition is still evolving. Patients with this syndrome are at increased risk for cardiovascular disease, and at increased risk of mortality from cardiovascular disease.

Metabolic syndrome is strongly associated with obesity, and more specifically with abdominal obesity. Abdominal obesity, comprises two main components: visceral (VAT) and subcutaneous (SAT) adipose tissue depots, with VAT reported as more metabolically active than SAT, and thought to play a major role in the metabolic disturbances associated with obesity and metabolic syndrome.

Non-alcoholic fatty liver disease (NAFLD) is fast becoming the most common liver disease and is associated with obesity, insulin resistance and metabolic syndrome.

Bariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome, NAFLD, and nonalcoholic steatohepatitis (NASH) in obese patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• All subjects must be approved by both insurance and site standard of care to undergo the Roux-en-Y gastric bypass procedure

• Male and Female Candidates for Roux-en-Y Bariatric Surgery

• Must be diagnosed with Metabolic Syndrome; having abdominal obesity and at least 2 other features of the syndrome per IDF (International Diabetes Foundation)

• Obese control group:Subjects should be obese and should not have any other features of metabolic syndrome.

Exclusion Criteria:

• Any subjects with prior bariatric surgery

• No other major surgery within the last 6 months

• Diabetes on treatment with hypoglycemic medication in the previous 6 months

Other exclusions apply

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Metabolic Syndrome X
• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Laparoscopic Roux-en-Y Gastric Bypass

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Italy,  Sweden,