Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT00283374

Collaborator

(none)

120

Enrollment

Locations

7.1

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity Metabolic Disease	Procedure: Laparoscopic Roux-en-Y Gastric Bypass

Study Design

Study Type:

Observational

Observational Model:

Defined Population

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

Study Start Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Irvine	California	United States	92697-1050
2	Orange	California	United States	92868
3	Atlanta	Georgia	United States	30322
4	Indianapolis	Indiana	United States	46278
5	Boston	Massachusetts	United States	02111
6	Minneapolis	Minnesota	United States	55455
7	Cleveland	Ohio	United States	44195
8	Pittsburgh	Pennsylvania	United States	15213
9	Pittsburgh	Pennsylvania	United States	15240
10	Dallas	Texas	United States	75390-9156
11	Aosta		Italy	11100
12	Pisa		Italy	56127
13	Roma		Italy	00168
14	Gothenburg		Sweden	413 45
15	Stockholm		Sweden	116 91
16	Stockholm		Sweden	141 86
17	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