Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Washington University School of Medicine Identifier:
First received: October 22, 2008
Last updated: October 23, 2008
Last verified: October 2008

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

Condition Intervention Phase
Behavioral: weight loss and exercise
Behavioral: weight loss
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Weight Loss and Exercise on Intrahepatic and Intramyocellular Fat in Obese Older Adults

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Intrahepatic fat Intramyocellular fat [ Time Frame: 6-month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Insulin sensitivity Physical Function [ Time Frame: 6-month ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: November 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
weight loss
Behavioral: weight loss
10 percent weight loss through diet and behavioral modification
Other Name: lifestyle change
Experimental: 2
Weight loss and exercise
Behavioral: weight loss and exercise
10% weight loss through diet and exercise plus multicomponent exercise training three times a week
Other Name: lifestyle modification

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.


Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00779207

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Dennis T Villareal, MD Washington University School of Medicine
  More Information

Responsible Party: Washington Universtiy School of Medicine, Washington University School of Medicine Identifier: NCT00779207     History of Changes
Other Study ID Numbers: DK 37948A, R01AG025501
Study First Received: October 22, 2008
Last Updated: October 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
weight loss
physical function
Obesity in the Elderly processed this record on February 27, 2015