Assessment of Changes in Abdominal Fat



Status:Active, not recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:4/20/2017
Start Date:June 2003
End Date:December 2020

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Assessment of Changes in Abdominal Fat and Metabolic and Tissue Biomarkers During a Bariatric Surgery Weight Loss Intervention Program

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.

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.

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
We found this trial at
1
site
West Lafayette, Indiana 47907
?
mi
from
West Lafayette, IN
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