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

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00779207
First received: October 22, 2008
Last updated: October 23, 2008
Last verified: October 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Obesity
 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:

U.S. FDA Resources

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779207

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

Publications:

Responsible Party: Washington Universtiy School of Medicine, Washington University School of Medicine
ClinicalTrials.gov 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:
obesity
aging
exercise
diet
 weight loss
physical function
Obesity in the Elderly

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

ClinicalTrials.gov processed this record on May 19, 2013