Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome
NCT ID: NCT00283374
Last Updated: 2006-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
120 participants
OBSERVATIONAL
2005-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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DEFINED_POPULATION
PROSPECTIVE
Interventions
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Laparoscopic Roux-en-Y Gastric Bypass
Eligibility Criteria
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Inclusion Criteria
* 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
* No other major surgery within the last 6 months
* Diabetes on treatment with hypoglycemic medication in the previous 6 months
Other exclusions apply
18 Years
55 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Irvine, California, United States
Orange, California, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Aosta, , Italy
Pisa, , Italy
Roma, , Italy
Gothenburg, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Countries
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Other Identifiers
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9804Z1-900
Identifier Type: -
Identifier Source: org_study_id