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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
weight loss and exercise
weight loss
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, aging, exercise, diet, weight loss, physical function, Obesity in the Elderly

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

weight loss

Weight loss and exercise

Outcomes

Primary Outcome Measures

Intrahepatic fat Intramyocellular fat

Secondary Outcome Measures

Insulin sensitivity Physical Function

Full Information

First Posted
October 22, 2008
Last Updated
October 23, 2008
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00779207
Brief Title
Effect of Weight Loss and Exercise on Liver and Muscle Fat in Obese Elderly
Official Title
Effect of Weight Loss and Exercise on Intrahepatic and Intramyocellular Fat in Obese Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, aging, exercise, diet, weight loss, physical function, Obesity in the Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
weight loss
Arm Title
2
Arm Type
Experimental
Arm Description
Weight loss and exercise
Intervention Type
Behavioral
Intervention Name(s)
weight loss and exercise
Other Intervention Name(s)
lifestyle modification
Intervention Description
10% weight loss through diet and exercise plus multicomponent exercise training three times a week
Intervention Type
Behavioral
Intervention Name(s)
weight loss
Other Intervention Name(s)
lifestyle change
Intervention Description
10 percent weight loss through diet and behavioral modification
Primary Outcome Measure Information:
Title
Intrahepatic fat Intramyocellular fat
Time Frame
6-month
Secondary Outcome Measure Information:
Title
Insulin sensitivity Physical Function
Time Frame
6-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis T Villareal, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15229329
Citation
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. doi: 10.1038/oby.2004.111.
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Effect of Weight Loss and Exercise on Liver and Muscle Fat in Obese Elderly

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