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Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00283374
First Posted: January 27, 2006
Last Update Posted: May 18, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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:


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

Estimated Enrollment: 120
Study Start Date: October 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00283374     History of Changes
Other Study ID Numbers: 9804Z1-900
First Submitted: January 25, 2006
First Posted: January 27, 2006
Last Update Posted: May 18, 2006
Last Verified: May 2006

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:
Syndrome
Metabolic Syndrome X
Obesity, Morbid
Metabolic Diseases
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms