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Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00283374
First received: January 25, 2006
Last updated: May 17, 2006
Last verified: May 2006
History of Changes
  Purpose

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.


Condition Intervention
Morbid Obesity
Metabolic Disease
 Procedure: Laparoscopic Roux-en-Y Gastric Bypass

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: A Prospective, Longitudinal Multicenter, Nontreatment, Exploratory Biomarker Study of Metabolic Syndrome in Subjects Undergoing Laparoscopic Roux-En-Y Gastric Bypass Bariatric Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Estimated Enrollment: 120
Study Start Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283374

Locations
United States, California
Irvine, California, United States, 92697-1050
Orange, California, United States, 92868
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Indiana
Indianapolis, Indiana, United States, 46278
United States, Massachusetts
Boston, Massachusetts, United States, 02111
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
Pittsburgh, Pennsylvania, United States, 15240
United States, Texas
Dallas, Texas, United States, 75390-9156
Italy
Aosta, Italy, 11100
Pisa, Italy, 56127
Roma, Italy, 00168
Sweden
Gothenburg, Sweden, 413 45
Stockholm, Sweden, 116 91
Stockholm, Sweden, 141 86
Stockholm, Sweden, 182- 88
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Italy, decresg@wyeth.com
Principal Investigator: Trial Manager For Sweden, MedInfoNord@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00283374     History of Changes
Other Study ID Numbers: 9804Z1-900
Study First Received: January 25, 2006
Last Updated: May 17, 2006
Health Authority: United States: Institutional Review Board
European Union: European Medicines Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Metabolic Syndrome
Obesity
Nonalcoholic fatty liver disease
Nonalcoholic steatohepatitis
Bariatric Surgery

Additional relevant MeSH terms:
Metabolic Diseases
Obesity
Obesity, Morbid
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on June 17, 2013