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Completed

NCT Number: NCT05784571

Assessment of Body Composition and Physical Function

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.

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Key information

Conditions

Body Composition Physical Function

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Body Composition Assessment

Other

Assessment of body composition using bioelectrical impedance analysis.

Modified Physical Performance Test

Other

A test of physical functioning

Hand grip strength

Other

A test of hand grip strength using a hand dynamometer.

6-minute walk test

Other

Self-paced test of walking capacity.

Measurement of blood glucose and insulin

Procedure

Blood will be drawn for measurement of glucose and insulin.

Primary outcomes

  1. Fat Mass

    Time frame: One day

    Measurement of fat mass

  2. Fat-free Mass

    Time frame: One day

    Measurement of fat-free mass

  3. Modified Physical Performance Test

    Time frame: One day

    Test for assessing physical performance. The scale ranges from 0 to 36 and higher score indicates a better outcome

Secondary outcomes

  1. Hand Grip Strength

    Time frame: One day

    Assessment of grip strength using a hand dynamometer

  2. 6-minute Walk Test

    Time frame: One day

    Test of walking capacity assessed as distance covered in 6 minutes

  3. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: One day

    Assessment of insulin resistance from blood glucose and insulin. HOMA-IR was calculated as: fasting insulin (μU/mL) × fasting glucose (mmol/L)]/22.5 Higher scores indicate greater insulin resistance and a worse outcome. There is no theoretical minimum and/or maximum value for HOMA-IR. Studies have suggested a variety of values that vary based on factors such as gender and age. For example, a large epidemiologic study found that HOMA-IR score of 1.85 in women and 2.17 in men indicated insulin resistance. In another study, the HOMA-IR cut point was found to be 2.37 and 2.38 in 70-year old men and women respectively (see references).

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Assessment of Body Composition and Physical Function in Older Adults With Obesity

Acronym: Perform

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2023
Registry last updated
Jul 30, 2024

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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