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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00283374 |
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Date of registration:
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25/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome
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Scientific title:
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A Prospective, Longitudinal Multicenter, Nontreatment, Exploratory Biomarker Study of Metabolic Syndrome in Subjects Undergoing Laparoscopic Roux-En-Y Gastric Bypass Bariatric Syndrome |
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Date of first enrolment:
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October 2005 |
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Target sample size:
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120 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00283374 |
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Study type:
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Observational |
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Study design:
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Observational Model: Defined Population, Time Perspective: Longitudinal
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Phase:
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N/A
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Countries of recruitment
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Italy
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Sweden
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Italy, decresg@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Sweden, MedInfoNord@wyeth.com |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Morbid Obesity
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Metabolic Disease
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Intervention(s)
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Procedure: Laparoscopic Roux-en-Y Gastric Bypass
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Secondary ID(s)
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9804Z1-900
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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