Assessment of Insulin Resistance, NAFLD, Predictors of CV Morbidity, and Subcutaneous Adipose and Visceral Adipose Gene Expression in Patients Undergoing Gastric Bypass Surgery

Insulin Resistance Clinical Trial

Official title:

Assessment of Insulin Resistance, Non-Alcoholic Fatty Liver Disease, Predictors of Cardiovascular Morbidity, and Subcutaneous Adipose and Visceral Adipose Gene Expression in Patients Undergoing Gastric Bypass: Development of a New Paradigm in Defining "Morbid Obesity" and in the Application of Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007955
• Other study ID #: H-12082
• Status: Completed
• Phase: N/A
• First received: November 3, 2009
• Last updated: August 23, 2012
• Start date: November 2006
• Est. completion date: May 2012

Study information

• Verified date: August 2012
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this research is to further study the effect weight loss after gastric bypass surgery has on the heart and blood pressure and on how the body uses or metabolizes the sugars, fats and proteins we eat. Additionally, the researchers want to study fat tissue for gene patterns which may be responsible for where we carry fat on our bodies, as well as look carefully at a possible link between adipose tissue and insulin resistance. The researchers also want to evaluate the liver for the presence of fatty liver, which is common in people with obesity and is associated with insulin resistance, as well as study the liver for gene patterns which may be associated with non-alcoholic liver disease.

Evaluating cardiovascular function and endocrine function before and after gastric bypass surgery, as well as studying adipose and liver tissue may help us understand the link between obesity, insulin resistance, fatty liver disease, high blood pressure and health problems such as diabetes and heart disease. Consequently, this may help in the future by identifying those who will benefit most from gastric bypass surgery.

Description:

Obesity is associated with insulin resistance and diabetes. Since both of these conditions have been implicated in cardiovascular complications, this association may explain obesity related illnesses and deaths. Gastric bypass is considered the "gold standard" surgical weightloss procedure and has been demonstrated to cure diabetes and insulin resistance. Some severely obese patients, however, have normal insulin-glucose metabolism. The differences in metabolic healthy in severely obese individuals has not been fully recognized or understood. This research will study insulin-glucose metabolism in a population of severely obese individuals undergoing gastric bypass. This investigation is based on the following hypotheses:

1. Severely obese individuals can be categorized by degree to which insulin-glucose homeostasis is impaired.

2. The degree of insulin resistance correlates with risk for cardiovascular disease. Weight loss in obese individuals with insulin resistance, will correlate with improvement in parameters associated with cardiovascular disease. Obese individuals with better insulin sensitivity will not have a high risk for cardiovascular disease and therefore will not experience this risk reduction in cardiovascular disease.

3. Insulin resistance is a consequence of pathological storage of excess energy intake; therefore, individuals who are insulin resistant and obese will differ from individuals who are obese, but not insulin resistant with regards to gene expression in subcutaneous adipose tissue and visceral adipose tissue.

Subjects will be studied for evidence of end organ dysfunction and predictors of morbidity and mortality preoperatively and postoperatively. Additionally, gene expression in the subcutaneous and visceral adipose depots of subjects will be studied

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Morbid Obesity

• Scheduled to undergo gastric bypass surgery

Exclusion Criteria:

• Pregnancy (would not be candidate for surgery)

• Nursing (would not be candidate for surgery)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fatty Liver
• Insulin Resistance
• Liver Diseases
• Morbid Obesity
• Non-Alcoholic Fatty Liver Disease
• Obesity, Morbid

Locations

Country	Name	City	State
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of insulin resistance and/or diabetes		Two weeks postoperatively, Six months postoperatively, One year postoperatively	No
Secondary	Improvement of cardiovascular risk factors		Two weeks postoperatively, Six months postoperatively, One year postoperatively	No