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Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome

Last updated on December 5, 2019

FOR MORE INFORMATION
Study Location
Irvine, California, 92697-1050 United States
Contact
1-800-718-1021
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

NCT00283374
Pfizer
Terminated
Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome

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Descriptive Information
Brief TitleStudy Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome
Official TitleA 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
Condition
  • Morbid Obesity
  • Metabolic Disease
InterventionProcedure: Laparoscopic Roux-en-Y Gastric Bypass
Study Groups/CohortsNot 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 StatusTerminated
Enrollment
 (submitted: January 25, 2006)
120
Original EnrollmentSame as current
Study Completion DateNot Provided
Primary Completion DateNot 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
Ages18 Years to 55 Years   (Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesItaly,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00283374
Other Study ID Numbers9804Z1-900
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyNot Provided
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot 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 AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateMay 2006

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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