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SarcopeniaNCT04122638

Prevalence of Sarcopenia and Sarcopenic Obesity in Older Adults

An observational study of Sarcopenia and Sarcopenic Obesity, run by Goztepe Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Syndromes such as sarcopenia, sarcopenic obesity and osteosarcopenic obesity are commonly seen in older adults. They result from the impairment of muscle, bone and adipose tissue. Thus, they lead to a decrease in quality of life and increase morbidity and mortality. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
How many people
572 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Oct 2019to 1 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: Community-dwelling older adults

Who may be able to join

  • Being at the age of 65 or older
  • Being able to complete 4-m walk test

Who cannot join

  • <24 points on Mini-Mental State Examination
  • 12 points or higher on Geriatric Depression Scale

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Goztepe Training and Research Hospital

    Istanbul, 34722

Other trials in Turkey (Türkiye)

About this study

Official title: Prevalence of Sarcopenia and Sarcopenic Obesity in Community-dwelling Outpatient Older Adults

Syndromes such as sarcopenia, sarcopenic obesity and osteosarcopenic obesity are commonly seen in older adults. They result from the impairment of muscle, bone and adipose tissue. Thus, they lead to a decrease in quality of life and increase morbidity and mortality. The aim of this study is to report the prevalence of sarcopenia, sarcopenic obesity and osteosarcopenic obesity in community-dwelling outpatient older adults and to investigate the related factors.

Keywords
Older adults
Medical subject headings
Sarcopenia, Bone Diseases, Metabolic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Handgrip Strength

    Handgrip strength measured by Takei© Hand Dynamometer

    Measured: 10 minutes

  2. Muscle mass

    Using Bioimpedance analysis (BİA) technique with TANITA© TBF 300

    Measured: 5 minutes

  3. Bone density

    T score evaluation using Dual-energy X-ray absorptiometry (DEXA)

    Measured: 30 minutes

  4. Percentage of body fat

    Using Bioimpedance analysis (BİA) technique with TANITA© TBF 300

    Measured: 5 minutes

Secondary outcomes (9)

  1. Gait speed

    4-m usual walking speed test

    Measured: 3 minutes

  2. Physical Activity

    Using Rapid Assessment of Physical Activity (RAPA)

    Measured: 5-10 minutes

  3. Nutritional Status

    Assessed with Mini-Nutritional Assessment (MNA)

    Measured: 10 minutes

  4. Activities of Daily Living

    Activities of daily living assessed with Katz Index of Independence in Activities of Daily Living

    Measured: 10 minutes

  5. Instrumental Activities of Daily Living

    Instrumental activities of daily living assessed with Lawton -Brody Instrumental Activities of Daily Living Scale

    Measured: 10 minutes

  6. Depression

    Assessed with The Geriatric Depression Scale- Short Form

    Measured: 10 minutes

  7. Mini-Mental State Examination

    Mini-Mental State Examination

    Measured: 10-15 minutes

  8. Blood Sample Analysis

    A blood sample analysis including parameters such as: wbc, hgb, htc, mcv ,plt, fasting blood sugar, urea, uric acid, creatin, AST, ALP, ALT, GGT, LDH, total colesterol, trigylicerid, LDL, HDL, NA, K, Mg, Ca, P, Albumin, protrombin time, CRP, B12, folate, iron, ferritin, PTH, vitamin-D, sedimentation, TSH, T4, insukin, HGBA1C, IHOMA-IR.

    Measured: 5 minutes

  9. Comorbidities

    Assessed with Charlson Comorbidity Index

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2019
  2. Study start7 Oct 2019
  3. Primary completion1 Jan 2020
  4. Study completion1 Jan 2020

Resources

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
Prospective
Enrolment
572 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04122638
Sponsor's protocol ID
GoztepeTRH
Status last verified
Feb 2020
First submitted
7 Oct 2019
Last updated
28 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
Individual data sharing
No

Publications

  • Demirdag F, Kolbasi EN, Aykut GB, Guler KY, Murat S, Ozturk GB, Oguz A. Nutritional status as a mediator between the age-related muscle loss and frailty in community-dwelling older adults. Arch Gerontol Geriatr. 2022 Jan-Feb;98:104569. doi: 10.1016/j.archger.2021.104569. Epub 2021 Nov 3.

    PubMed 34768160

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Sarcopenic Obesity, run by Goztepe Training and Research Hospital at 1 site in Turkey (Türkiye).

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 28 Feb 2020. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Handgrip Strength (time frame: 10 minutes). The study lists 4 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 NCT04122638, which also lists 1 linked publication.

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 28 Feb 2020.

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