- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00283374
Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome
A Prospective, Longitudinal Multicenter, Nontreatment, Exploratory Biomarker Study of Metabolic Syndrome in Subjects Undergoing Laparoscopic Roux-En-Y Gastric Bypass Bariatric Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Contacts and Locations
Study Locations
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Aosta, Italy, 11100
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Pisa, Italy, 56127
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Roma, Italy, 00168
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Gothenburg, Sweden, 413 45
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Stockholm, Sweden, 141 86
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Stockholm, Sweden, 116 91
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Stockholm, Sweden, 182- 88
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California
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Irvine, California, United States, 92697-1050
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Orange, California, United States, 92868
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Georgia
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Atlanta, Georgia, United States, 30322
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Indiana
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Indianapolis, Indiana, United States, 46278
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Massachusetts
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Boston, Massachusetts, United States, 02111
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Minnesota
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Minneapolis, Minnesota, United States, 55455
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Ohio
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Cleveland, Ohio, United States, 44195
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15240
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Pittsburgh, Pennsylvania, United States, 15213
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Texas
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Dallas, Texas, United States, 75390-9156
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Trial Manager, For Italy, decresg@wyeth.com
- Principal Investigator: Trial Manager, For Sweden, MedInfoNord@wyeth.com
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9804Z1-900
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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