Effect of Weight Loss and Exercise on Liver and Muscle Fat in Obese Elderly - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00779207

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 III

MedlinePlus related topics: Diets Exercise and Physical Fitness Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Effect of Weight Loss and Exercise on Intrahepatic and Intramyocellular Fat in Obese Older Adults

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
1: Experimental weight loss	Behavioral: weight loss 10 percent weight loss through diet and behavioral modification
2: Experimental Weight loss and exercise	Behavioral: weight loss and exercise 10% weight loss through diet and exercise plus multicomponent exercise training three times a week

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:

Villareal DT, Banks M, Siener C, Sinacore DR, Klein S. Physical frailty and body composition in obese elderly men and women. Obes Res. 2004 Jun;12(6):913-20.

Responsible Party:	Washington University School of Medicine ( Washington Universtiy School of Medicine )
Study ID Numbers:	DK 37948A, R01AG025501
Study First Received:	October 22, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00779207 History of Changes
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

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009