Status:
TERMINATED
Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Morbid Obesity
Metabolic Disease
Eligibility:
All Genders
18-55 years
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00283374
Start Date
October 1 2005
Last Update
May 18 2006
Active Locations (17)
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1
Irvine, California, United States, 92697-1050
2
Orange, California, United States, 92868
3
Atlanta, Georgia, United States, 30322
4
Indianapolis, Indiana, United States, 46278