Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome

NCT00283374

Last updated date
Study Location
Irvine, California, 92697-1050, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Morbid Obesity, Metabolic Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Morbid Obesity, Metabolic DiseaseStudy Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome
NCT00283374
  1. Irvine, California
  2. Orange, California
  3. Atlanta, Georgia
  4. Indianapolis, Indiana
  5. Boston, Massachusetts
  6. Minneapolis, Minnesota
  7. Cleveland, Ohio
  8. Pittsburgh, Pennsylvania
  9. Pittsburgh, Pennsylvania
  10. Dallas, Texas
  11. Aosta,
  12. Pisa,
  13. Roma,
  14. Gothenburg,
  15. Stockholm,
  16. Stockholm,
  17. Stockholm,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Morbid Obesity
  • Metabolic Disease
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
 (submitted: January 25, 2006)
120
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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

Sex/Gender
Sexes Eligible for Study:All
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
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor Sweden, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date May 2006