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View Clinical Trial (Medical Research Study)
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Assessment of Changes in Abdominal Fat - NCT00228579-30322 (Clinical Trial 131369)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy131369.aspx
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| City: |
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Atlanta |
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State:
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GA |
| Zip Code: |
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30322 |
| Conditions: |
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Obesity |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 3, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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