- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07510009
Determination of Skeletal Muscle Mass Index Values in the Turkish Population Using Dual Energy X-Ray Absorptiometry
Sarcopenia is defined by the European Working Group on Sarcopenia in Older People (EWGSOP) as "a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, carrying a risk of adverse outcomes such as physical disability, fractures, falls, impaired quality of life, and death." However, despite the severity of the disease, a single diagnostic criterion has not yet been established, and various guidelines have been proposed to standardize the diagnostic criteria and cut-off values. Current European Working Group on Sarcopenia in Older People (EWGSOP) recommendations focus on European populations and, where possible, the use of normative references from healthy young adults. Since measurements such as gait and muscle strength are height-dependent, the use of regional normative populations is recommended whenever possible. Currently, some cut-off points for the diagnosis of sarcopenia are arbitrary. The development of validated cut-off points will depend on normative data and their predictive value for endpoints. Further studies are needed to determine whether gender-specific and region-specific threshold values for the diagnosis of sarcopenia improve the prediction of sarcopenia outcomes.
There are no studies in the literature on dual-energy x-ray absorptiometry cutoff values specific to the Turkish population. In our study, we aimed to define reference cutoff values for muscle mass, muscle strength, and calf circumference in Türkiye in order to improve the general applicability of EWGSOP criteria.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Having mental and physical capacity
- Being between 18-39 and 65-99 years of age
- Being able to ambulate independently or with support
Exclusion Criteria:
- Pregnancy
- Infection
- Pacemaker or metallic implant
- Peripheral circulatory disorder
- Known concomitant malignancy, end-stage organ failure
- Known concomitant central nervous system and/or peripheral nervous system disease
- History of genetic disease
- Coagulopathy
- Amputation
- Patients with a history of genetic disease
- Patients weighing >120 kg
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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young population
Ages 18-39
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elderly population
Ages 65-99
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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skeletal muscle mass index
Time Frame: At the start of the work
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Skeletal muscle mass index: calculated by dividing the sum of the non-bone lean mass of the four extremities by height² (meters).
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At the start of the work
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
muscle strength
Time Frame: at the start of the work
|
Muscle strength will be assessed by measuring hand grip strength using the Baseline hydraulic hand dynamometer (INC.
White Plains NY 10602 U.S.A), which has proven validity and reliability.
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at the start of the work
|
|
walking speed test
Time Frame: at the start of the work
|
For the walking speed test, participants will be asked to walk 4 meters at their normal pace.
Walking speed will be measured in m/s.
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at the start of the work
|
|
Calf circumference
Time Frame: at the start of the work
|
Calf circumference will be measured at the widest part of the calf.
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at the start of the work
|
|
Mid-arm circumference
Time Frame: at the start of the work
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Mid-arm circumference will be measured standing with the shoulder abducted at 90 degrees, at the midsection of the humerus.
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at the start of the work
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayşe U Baykut, Ankara City Hospital Bilkent
- Study Chair: Güldal F Yüzer Nakipoğlu, Ankara City Hospital Bilkent
- Study Chair: Zeynep S Güneş, Ankara City Hospital Bilkent
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACHBİLKENTAUBAYKUT003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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