- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05784571
Assessment of Body Composition and Physical Function (Perform)
June 7, 2023 updated by: Candida Rebello, Pennington Biomedical Research Center
Assessment of Body Composition and Physical Function in Older Adults With Obesity
Sarcopenia, which is the loss of muscle mass and strength or physical function, naturally occurs in aging.
In sarcopenic obesity, growth of muscle mass and increments in strength do not parallel weight gain, and places older adults at increased risk of falls, fractures, physical disability, frailty, and mortality from too low muscle strength relative to body size.
The goal of the study is to assess body composition and physical function in older adults with obesity.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a cross-sectional study in 40 adults aged 60 to 80 years with obesity.
Body composition, physical function, and insulin resistance will be measured.
Subjects who satisfy the eligibility criteria and sign the informed consent will be enrolled.
Subjects will complete an assessment of body composition by bioelectrical impedance analysis and tests of physical performance.
Blood will be drawn for measurement of fasting glucose and insulin.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Candida J Rebello, Ph.D.
- Phone Number: 2252882411
- Email: Candida.Rebello@pbrc.edu
Study Contact Backup
- Name: Frank L Greenway, MD
- Phone Number: 2257632=2578
- Email: Frank.Greenway@pbrc.edu
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adults aged 60 - 80 years with obesity.
Description
Inclusion Criteria:
- Body mass index > 30kg/m2
- Age 60 - 80 years
Exclusion Criteria:
- self-reported history of diabetes, or cancer or significant cardiovascular or hepatic or renal disease or dysfunction.
- clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, or celiac disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Older Adults
Adults 60-80 years of age with body mass index > 30kg/m2
|
Assessment of body composition using bioelectrical impedance analysis.
A test of physical functioning
A test of hand grip strength using a hand dynamometer.
Self-paced test of walking capacity.
Blood will be drawn for measurement of glucose and insulin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat mass
Time Frame: One day
|
Measurement of fat mass
|
One day
|
Fat-free mass
Time Frame: One day
|
Measurement of fat-free mass
|
One day
|
Modified Physical Performance Test
Time Frame: One day
|
Assessment of physical function
|
One day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hand grip strength
Time Frame: One day
|
Assessment of grip strength using a hand dynamometer
|
One day
|
6-minute walk test
Time Frame: One day
|
Test of walking capacity assessed as distance covered in 6 minutes
|
One day
|
Insulin resistance
Time Frame: One day
|
Assessment of insulin resistance from blood glucose and insulin
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Candida J Rebello, Ph.D., Pennington Biomedical Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2023
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
June 1, 2023
Study Registration Dates
First Submitted
March 1, 2023
First Submitted That Met QC Criteria
March 13, 2023
First Posted (Actual)
March 27, 2023
Study Record Updates
Last Update Posted (Actual)
June 8, 2023
Last Update Submitted That Met QC Criteria
June 7, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2023-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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