Body CompositionPerformNCT05784571
Assessment of Body Composition and Physical Function
An observational study of Body Composition and Physical Function, run by Pennington Biomedical Research Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Body Composition, Physical Function
- What is being tested?
- Body Composition Assessment, Modified Physical Performance Test and Hand grip strength
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to 1 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 60 - 80 years with obesity.
Who may be able to join
- Body mass index > 30kg/m2
- Age 60 - 80 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: 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.
Read the 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.
- Conditions
- Body Composition, Physical Function
- Being tested
- Body Composition Assessment, Modified Physical Performance Test, Hand grip strength, 6-minute walk test, Measurement of blood glucose and insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Composition AssessmentOther
Assessment of body composition using bioelectrical impedance analysis.
Modified Physical Performance TestOther
A test of physical functioning
Hand grip strengthOther
A test of hand grip strength using a hand dynamometer.
6-minute walk testOther
Self-paced test of walking capacity.
Measurement of blood glucose and insulinProcedure or surgery
Blood will be drawn for measurement of glucose and insulin.
| Study group | Role | What they receive |
|---|---|---|
| Older Adults | Adults 60-80 years of age with body mass index > 30kg/m2 Receives: Other: Body Composition Assessment; Other: Modified Physical Performance Test; Other: Hand grip strength; Other: 6-minute walk test; Procedure: Measurement of blood glucose and insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Mass
Measurement of fat mass
Measured: One day
Fat-free Mass
Measurement of fat-free mass
Measured: 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
Measured: One day
Secondary outcomes (3)
Hand Grip Strength
Assessment of grip strength using a hand dynamometer
Measured: One day
6-minute Walk Test
Test of walking capacity assessed as distance covered in 6 minutes
Measured: 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).
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start13 Mar 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candida Rebello, Pennington Biomedical Research Center
- Investigators
- Candida J Rebello, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784571
- Sponsor's protocol ID
- PBRC 2023-001
- Acronym
- Perform
- Status last verified
- Jul 2024
- First submitted
- 1 Mar 2023
- Last updated
- 30 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24131857Ghasemi 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.
PubMed 25794879
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Body Composition and Physical Function in Older Adults With Obesity
- ClinicalTrials.gov ID
- NCT05784571
- Acronym / sponsor ID
- Perform / PBRC 2023-001
- Conditions
- Body Composition, Physical Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Posted 30 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older Adults | – | Other: Body Composition Assessment, Other: Modified Physical Performance Test, Other: Hand grip strength, Other: 6-minute walk test, Procedure: Measurement of blood glucose and insulinAdults 60-80 years of age with body mass index > 30kg/m2 |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 60 - 80 years with obesity.
Key inclusion criteria (2 listed)
- Body mass index > 30kg/m2
- Age 60 - 80 years
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Composition AssessmentAssessment of body composition using bioelectrical impedance analysis. | Other | Older Adults |
| Modified Physical Performance TestA test of physical functioning | Other | Older Adults |
| Hand grip strengthA test of hand grip strength using a hand dynamometer. | Other | Older Adults |
| 6-minute walk testSelf-paced test of walking capacity. | Other | Older Adults |
| Measurement of blood glucose and insulinBlood will be drawn for measurement of glucose and insulin. | Procedure or surgery | Older Adults |
Primary outcome
Fat Mass
Time frame: One day
Measurement of fat mass
Fat-free Mass
Time frame: One day
Measurement of fat-free mass
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
3 secondary outcomes
Hand Grip Strength
Time frame: One day
6-minute Walk Test
Time frame: One day
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: One day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24131857Gayoso-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.
- Background: PubMed 25794879Ghasemi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candida J Rebello, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Composition and Physical Function, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat Mass (time frame: One day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05784571, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024; AzTrials last refreshed its copy on 28 Oct 2026.