This trial is active, not recruiting.

Condition obesity
Sponsor Purdue University
Collaborator National Institutes of Health (NIH)
Start date June 2003
End date December 2016
Trial size 60 participants
Trial identifier NCT00228579, 333-2002, DK-067167


In this study, we propose to determine the effect of weight loss on amount of body fat, and on body fat distribution, in severely obese patients. We also want to determine what measurements (waist, hip or thigh circumference) best show the changes in body fat and fat distribution in this group. Most importantly, we want to relate the changes in body measurements to changes in health indicators (blood cholesterol, blood pressure, blood sugars, liver function). With the findings of this study, clinicians should be able to predict an improvement in health based on a change in waist, hip or thigh size. Because this is a pilot study, we will focus on women, who make up the bulk of our clinic population. We will also focus on racial differences between Caucasians and Blacks.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Subjects will be recruited from patients undergoing bariatric surgery at Emory Bariatrics. The cost of surgical procedures will not be provided by the research study.

Primary Outcomes

Visceral adipose tissue volume
time frame: Baseline, 1, 6 and 24 months

Secondary Outcomes

Insulin sensitivity
time frame: Baseline, 1, 6, 24 months

Eligibility Criteria

Female participants from 18 years up to 65 years old.

Exclusion Criteria: 1. male [this will be a pilot study limited to females. Gender is known to influence adipose tissue distribution and females represent the majority of the Emory Bariatrics population - 89%], 2. age less than 18 or greater than 65 y, [aging has been independently associated with insulin resistance] 3. pregnancy 4. not eligible for treatment due to medical history (due to cardiac, hepatic or psychiatric problems, or immunocompromise), 5. tobacco smoker

Additional Information

Official title Assessment of Changes in Abdominal Fat and Metabolic and Tissue Biomarkers During a Bariatric Surgery Weight Loss Intervention Program
Principal investigator Nana Gletsu Miller, Ph.D.
Description Severe obesity affects 4.7% of the U.S. population. A significant number of these individuals suffer from impaired glucose tolerance and type II diabetes due to insulin resistance (IR). Although it is generally accepted that the accumulation of intraabdominal (IA) fat increases the risk of developing IR, the mechanisms responsible for this phenomenon are not yet understood. In addition, the role of subcutaneous (SC) fat towards the etiology of IR - protective, inert or detrimental - is still under debate. This is because SC adipose tissue releases adipocytokines (IL-6, leptin, TNF-a) that have been demonstrated to impair insulin action. In individuals who are severely obese, hyperinsulinemia may induce an exaggerated production of adipocytokines from IA compared to SC fat stores. Our specific aims are: (1) to determine relative contribution of abdominal SC fat versus IA fat to systemic levels of IL-6, leptin and TNF-a in lean and in severely obese individuals; (2) to determine the effects of systemic adipocytokine concentrations on whole body as well as tissue sensitivity to insulin. Hypothesis: (a) In the context of severe obesity, IA fat produces increased quantities of IL-6, leptin and TNF-a compared to SC fat; (b) In severely obese patients undergoing weight loss, whole body and tissue IR can be predicted by changes in systemic adipocytokines. Methods: Adipose tissue content of IL-6, leptin and TNF-a will be determined by ELISA in biopsies obtained from IA and SC fat stores in lean and severely obese patients. Computer tomography-determined areas of IA and SC fat will be related to changes in systemic adipocytokines at baseline and 6-mo following weight loss therapy. Changes in systemic IL-6, leptin and TNF-a will be assessed from measurements made at baseline and following 6-mo weight loss. For this time period we will also determine changes in whole body (via IVGTT) and tissue sensitivity to insulin (via glucose uptake into muscle and fat). Relationships between systemic adipocytokines and IR will be assessed using uni- and multivariate correlation analysis. These novel studies will determine whether hypersecretion of adipocytokines by IA versus SC adipose tissue induces IR in patients with severe obesity.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Purdue University.