Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228579
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2005-09-27
Brief Title:
Assessment of Changes in Abdominal Fat
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Assessment of Changes in Abdominal Fat and Metabolic and Tissue Biomarkers During a Bariatric Surgery Weight Loss Intervention Program
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Severe obesity affects 47 of the US 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DK-067167 | None | None | None |