Effect of Weight Loss and Exercise on Liver and Muscle Fat in Obese Elderly

Phase 3

Completed

• Conditions: Obesity
• Interventions: Behavioral: weight loss; Behavioral: weight loss and exercise

• Registration Number: NCT00779207
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this study is to determine the effect of weight loss and exercise on liver and muscle fat.

Detailed Description

Obesity causes serious medical complications and impairs quality of life. Moreover, both aging and obesity cause metabolic and physical dysfunction. The primary objectives of the proposed research are to evaluate the independent and combined effects of weight loss and exercise on Intrahepatic and Intramyocellular fat in obese elderly men and women. The central hypothesis is that in obese elderly subjects, weight loss will improve metabolic and physical function while the addition of exercise will not only augment improvement in these outcomes, but also attenuate the adverse effects of weight loss on bone and muscle masses. To test this hypothesis, 20 elderly (65-85 years old) obese men and women (body mass index \[BMI\] \> 30 kg/m2) with physical frailty will be randomized to 2 treatment groups: 1)10% weight loss, 2) 10% weight loss plus exercise training.

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2008-10
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-23
• Last Update Submitted: 2008-10-23
• Study First Posted: 2008-10-24
• Last Update Posted: 2008-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Obese (BMI 30 or greater)
• Elderly (age 65 years or older)

Exclusion Criteria

• Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results. Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	weight loss	weight loss
2	weight loss and exercise	Weight loss and exercise

Primary Outcome Measures

Name	Time	Method
Intrahepatic fat Intramyocellular fat	6-month

Secondary Outcome Measures

Name	Time	Method
Insulin sensitivity Physical Function	6-month

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States