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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05784571
Other study ID # PBRC 2023-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 13, 2023
Est. completion date June 1, 2023

Study information

Verified date June 2023
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Body Composition Assessment
Assessment of body composition using bioelectrical impedance analysis.
Modified Physical Performance Test
A test of physical functioning
Hand grip strength
A test of hand grip strength using a hand dynamometer.
6-minute walk test
Self-paced test of walking capacity.
Procedure:
Measurement of blood glucose and insulin
Blood will be drawn for measurement of glucose and insulin.

Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fat mass Measurement of fat mass One day
Primary Fat-free mass Measurement of fat-free mass One day
Primary Modified Physical Performance Test Assessment of physical function One day
Secondary Hand grip strength Assessment of grip strength using a hand dynamometer One day
Secondary 6-minute walk test Test of walking capacity assessed as distance covered in 6 minutes One day
Secondary Insulin resistance Assessment of insulin resistance from blood glucose and insulin One day
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