Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome
NCT00283374
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Adult Trials: 18+ Years
- 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.
- 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
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| Descriptive Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title | Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome | |||||||||
| Official Title | A Prospective, Longitudinal Multicenter, Nontreatment, Exploratory Biomarker Study of Metabolic Syndrome in Subjects Undergoing Laparoscopic Roux-En-Y Gastric Bypass Bariatric Syndrome | |||||||||
| 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 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. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Defined Population Time Perspective: Prospective | |||||||||
| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Not Provided | |||||||||
| Study Population | Not Provided | |||||||||
| Condition |
| |||||||||
| Intervention | Procedure: Laparoscopic Roux-en-Y Gastric Bypass | |||||||||
| Study Groups/Cohorts | Not Provided | |||||||||
| Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status | Terminated | |||||||||
| Enrollment | 120 | |||||||||
| Original Enrollment | Same as current | |||||||||
| Study Completion Date | Not Provided | |||||||||
| Primary Completion Date | Not Provided | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
Other exclusions apply | |||||||||
| Sex/Gender |
| |||||||||
| Ages | 18 Years to 55 Years (Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Italy, Sweden, United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT00283374 | |||||||||
| Other Study ID Numbers | 9804Z1-900 | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Not Provided | |||||||||
| Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
| |||||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
| Verification Date | May 2006 | |||||||||