Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome

A Prospective, Longitudinal Multicenter, Nontreatment, Exploratory Biomarker Study of Metabolic Syndrome in Subjects Undergoing Laparoscopic Roux-En-Y Gastric Bypass Bariatric Syndrome

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00283374

Enrollment

120

Registered

2006-01-27

Start date

2005-10-31

Completion date

Unknown

Last updated

2006-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity, Metabolic Disease

Keywords

Metabolic Syndrome, Obesity, Nonalcoholic fatty liver disease, Nonalcoholic steatohepatitis, Bariatric Surgery

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.

Interventions

PROCEDURELaparoscopic Roux-en-Y Gastric Bypass

Study design

Observational model

DEFINED_POPULATION

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Countries

Italy, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026