Body Composition, Physical Function
Conditions
Brief 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.
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.
Interventions
OTHERModified Physical Performance Test
A test of physical functioning
OTHERHand grip strength
A test of hand grip strength using a hand dynamometer.
OTHER6-minute walk test
Self-paced test of walking capacity.
PROCEDUREMeasurement of blood glucose and insulin
Blood will be drawn for measurement of glucose and insulin.
Assessment of body composition using bioelectrical impedance analysis.
Sponsors
Pennington Biomedical Research Center
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat Mass | One day | Measurement of fat mass |
| Fat-free Mass | One day | Measurement of fat-free mass |
| Modified Physical Performance Test | One day | Test for assessing physical performance. The scale ranges from 0 to 36 and higher score indicates a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand Grip Strength | One day | Assessment of grip strength using a hand dynamometer |
| 6-minute Walk Test | One day | Test of walking capacity assessed as distance covered in 6 minutes |
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Older Adults Adults 60-80 years of age with body mass index \> 30kg/m2
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.
Measurement of blood glucose and insulin: Blood will be drawn for measurement of glucose and insulin. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Older Adults |
|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 5.01 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Fat-free Mass
Measurement of fat-free mass
Time frame: One day
Population: Older adults
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Older Adults | Fat-free Mass | 55.88 Kg | Standard Deviation 12.08 |
Primary
Fat Mass
Measurement of fat mass
Time frame: One day
Population: Older adults
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Older Adults | Fat Mass | 44.71 Kg | Standard Deviation 13.13 |
Primary
Modified Physical Performance Test
Test for assessing physical performance. The scale ranges from 0 to 36 and higher score indicates a better outcome
Time frame: One day
Population: Older adults
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Older Adults | Modified Physical Performance Test | 30 score on a scale | Standard Deviation 5.85 |
Secondary
6-minute Walk Test
Test of walking capacity assessed as distance covered in 6 minutes
Time frame: One day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Older Adults | 6-minute Walk Test | 1375.25 Feet | Standard Deviation 416.63 |
Secondary
Hand Grip Strength
Assessment of grip strength using a hand dynamometer
Time frame: One day
Population: Average of the left- and right-hand grip strength measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Older Adults | Hand Grip Strength | 27.98 kilograms | Standard Deviation 9.36 |
Secondary
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
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).
Time frame: One day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Older Adults | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 4.7 Score on a scale | Standard Deviation 3.4 |