NCT00283374

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Geographic Reach
3 countries

17 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
Last Updated

May 18, 2006

Status Verified

May 1, 2006

First QC Date

January 25, 2006

Last Update Submit

May 17, 2006

Conditions

Morbid ObesityMetabolic Disease

Keywords

Metabolic SyndromeObesityNonalcoholic fatty liver diseaseNonalcoholic steatohepatitisBariatric Surgery

Interventions

Laparoscopic Roux-en-Y Gastric BypassPROCEDURE

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Irvine, California, 92697-1050, United States

Location

Unknown Facility

Orange, California, 92868, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Indianapolis, Indiana, 46278, United States

Location

Unknown Facility

Boston, Massachusetts, 02111, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55455, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15240, United States

Location

Unknown Facility

Dallas, Texas, 75390-9156, United States

Location

Unknown Facility

Aosta, 11100, Italy

Location

Unknown Facility

Pisa, 56127, Italy

Location

Unknown Facility

Roma, 00168, Italy

Location

Unknown Facility

Gothenburg, 413 45, Sweden

Location

Unknown Facility

Stockholm, 116 91, Sweden

Location

Unknown Facility

Stockholm, 141 86, Sweden

Location

Unknown Facility

Stockholm, 182- 88, Sweden

Location

MeSH Terms

Conditions

Obesity, MorbidMetabolic DiseasesMetabolic SyndromeObesityNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersFatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Italy, decresg@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For Sweden, MedInfoNord@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 27, 2006

Study Start

October 1, 2005

Last Updated

May 18, 2006

Record last verified: 2006-05

Locations

IT(3)SE(4)US(10)