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Completed

NCT Number: NCT00779207

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

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

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

weight loss and exercise

Behavioral

10% weight loss through diet and exercise plus multicomponent exercise training three times a week

Other names: lifestyle modification

Weight Loss

Behavioral

10 percent weight loss through diet and behavioral modification

Other names: lifestyle change

Primary outcomes

  1. Intrahepatic fat Intramyocellular fat

    Time frame: 6-month

Secondary outcomes

  1. Insulin sensitivity Physical Function

    Time frame: 6-month

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Effect of Weight Loss and Exercise on Intrahepatic and Intramyocellular Fat in Obese Older Adults

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 24, 2008
Registry last updated
Oct 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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