Assessment of Changes in Abdominal Fat

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nana Gletsu-Miller, Purdue University
ClinicalTrials.gov Identifier:
NCT00228579
First received: September 27, 2005
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Changes in Abdominal Fat and Metabolic and Tissue Biomarkers During a Bariatric Surgery Weight Loss Intervention Program

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Visceral adipose tissue volume [ Time Frame: Baseline, 1, 6 and 24 months ] [ Designated as safety issue: No ]
    Visceral adipose tissue volume is measured by computed tomography


Secondary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Baseline, 1, 6, 24 months ] [ Designated as safety issue: No ]
    Insulin sensitivity is measured by intravenous glucose tolerance test.


Estimated Enrollment: 60
Study Start Date: June 2003
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00228579

Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47906
Sponsors and Collaborators
Purdue University
Investigators
Principal Investigator: Nana Gletsu Miller, Ph.D. Purdue University
  More Information

Publications:

Responsible Party: Nana Gletsu-Miller, Assistant Professor, Foods and Nutrition, Purdue University
ClinicalTrials.gov Identifier: NCT00228579     History of Changes
Other Study ID Numbers: 333-2002, DK-067167
Study First Received: September 27, 2005
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
diabetes
insulin resistance

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014