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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Older Adults | Adults 60-80 years of age with body mass index > 30kg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body Composition Assessment | Other | Assessment of body composition using bioelectrical impedance analysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fat Mass | Measurement of fat mass | One day |
| Fat-free Mass | Measurement of fat-free mass | One day |
| Modified Physical Performance Test | Test for assessing physical performance. The scale ranges from 0 to 36 and higher score indicates a better outcome | One day |
| Measure | Description | Time Frame |
|---|---|---|
| Hand Grip Strength | Assessment of grip strength using a hand dynamometer | One day |
| 6-minute Walk Test | Test of walking capacity assessed as distance covered in 6 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged 60 - 80 years with obesity.
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| Name | Affiliation | Role |
|---|---|---|
| Candida J Rebello, Ph.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24131857 | Background | Gayoso-Diz P, Otero-Gonzalez A, Rodriguez-Alvarez MX, Gude F, Garcia F, De Francisco A, Quintela AG. Insulin resistance (HOMA-IR) cut-off values and the metabolic syndrome in a general adult population: effect of gender and age: EPIRCE cross-sectional study. BMC Endocr Disord. 2013 Oct 16;13:47. doi: 10.1186/1472-6823-13-47. | |
| 25794879 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fat Mass | Measurement of fat mass | Older adults | Posted | Mean | Standard Deviation | Kg | One day |
|
|
Study was conducted over one visit.
Adverse events were monitored and the presence or absence of an event was recorded during the conduct of the study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Candida Rebello | Pennington Biomedical Research Center, Baton Rouge, LA | 2257633159 | Candida.Rebello@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 3, 2023 | Jun 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018737 | Hand Strength |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D053580 | Muscle Strength |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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. |
|
| One day |
| 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). | One day |
| Ghasemi A, Tohidi M, Derakhshan A, Hasheminia M, Azizi F, Hadaegh F. Cut-off points of homeostasis model assessment of insulin resistance, beta-cell function, and fasting serum insulin to identify future type 2 diabetes: Tehran Lipid and Glucose Study. Acta Diabetol. 2015 Oct;52(5):905-15. doi: 10.1007/s00592-015-0730-3. Epub 2015 Mar 22. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Fat-free Mass | Measurement of fat-free mass | Older adults | Posted | Mean | Standard Deviation | Kg | One day |
|
|
|
| Primary | Modified Physical Performance Test | Test for assessing physical performance. The scale ranges from 0 to 36 and higher score indicates a better outcome | Older adults | Posted | Mean | Standard Deviation | score on a scale | One day |
|
|
|
| Secondary | Hand Grip Strength | Assessment of grip strength using a hand dynamometer | Average of the left- and right-hand grip strength measurement. | Posted | Mean | Standard Deviation | kilograms | One day |
|
|
|
| Secondary | 6-minute Walk Test | Test of walking capacity assessed as distance covered in 6 minutes | Posted | Mean | Standard Deviation | Feet | One day |
|
|
|
| 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). | Posted | Mean | Standard Deviation | Score on a scale | One day |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |