Assessment of Changes in Abdominal Fat

August 3, 2022 updated by: Nana Gletsu Miller, Indiana University

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47906
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Severely obese volunteers who are undergoing bariatric surgery. Subjects will be recruited from patients who are undergoing bariatric surgery procedures at Emory Bariatrics. The costs of surgical procedures are not provided by the research study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Bariatric Surgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visceral adipose tissue volume
Time Frame: Baseline, 1, 6 and 24 months
Visceral adipose tissue volume is measured by computed tomography
Baseline, 1, 6 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: Baseline, 1, 6, 24 months
Insulin sensitivity is measured by intravenous glucose tolerance test.
Baseline, 1, 6, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Nana Gletsu Miller, Ph.D., Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 333-2002
  • DK-067167

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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