SarcopeniaNCT07510009
Determination of Skeletal Muscle Mass Index Values in the Turkish Population Using Dual Energy X-Ray Absorptiometry
An observational study of Sarcopenia and Sarcopenia in Elderly, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
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."… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Sarcopenia in Elderly
- How many people
- 145 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2024to 30 May 2026
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: city hospital
Who may be able to join
- Having mental and physical capacity
- Being between 18-39 and 65-99 years of age
- Being able to ambulate independently or with support
Who cannot join
- 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
Show all 11Show fewer
- History of genetic disease
- Coagulopathy
- Amputation
- Patients with a history of genetic disease
- Patients weighing >120 kg
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
When low muscle strength is detected, the patient is evaluated for possible sarcopenia; the diagnosis is confirmed by the presence of low muscle mass or quality. Severe sarcopenia is considered when low muscle strength, low muscle mass or quality are accompanied by low physical performance. Muscle strength can be assessed by measuring hand grip strength and isometric or isokinetic measurements of lower extremity strength. A wide variety of techniques are used to measure muscle mass, including magnetic resonance imaging (MRI), computed tomography (CT), dual-energy x-ray absorptiometry (DEXA), bioelectrical impedance analysis (BIA), and anthropometric measurements; the most suitable method should be determined based on cost, accessibility, and ease of use. Muscle mass is related to body size; that is, individuals with larger body sizes typically have greater muscle mass. Therefore, to adjust for body size, the skeletal muscle index (SMI) is calculated as appendicular skeletal muscle mass (ALM) / height² (m²). The SMI cut-off value for sarcopenia, as defined by EWGSOP2, is <5.5 kg/m² for women and <7.0 kg/m² for men. There is ongoing debate regarding the preferred adjustment and whether the same method can be used for all populations. Physical performance assessment can be measured in various ways, including walking speed, the Short Physical Performance Battery (SPPB), and the Timed Up and Go Test (TUG).
- Conditions
- Sarcopenia, Sarcopenia in Elderly
- Keywords
- sarcopenia, sarcopenia in elderly
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| young population | Ages 18-39 | |
| elderly population | Ages 65-99 |
What is being measured
The primary outcome is the main question the study is designed to answer.
skeletal muscle mass index
Skeletal muscle mass index: calculated by dividing the sum of the non-bone lean mass of the four extremities by height² (meters).
Measured: At the start of the work
Secondary outcomes (4)
muscle strength
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.
Measured: at the start of the work
walking speed test
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.
Measured: at the start of the work
Calf circumference
Calf circumference will be measured at the widest part of the calf.
Measured: at the start of the work
Mid-arm circumference
Mid-arm circumference will be measured standing with the shoulder abducted at 90 degrees, at the midsection of the humerus.
Measured: at the start of the work
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start30 Jun 2024
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Ukbe Baykut, Ankara City Hospital Bilkent
- Investigators
- Ayşe U Baykut, Principal investigator, Ankara City Hospital BilkentGüldal F Yüzer Nakipoğlu, Study chair, Ankara City Hospital BilkentZeynep S Güneş, Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510009
- Sponsor's protocol ID
- ACHBİLKENTAUBAYKUT003
- Status last verified
- Jun 2026
- First submitted
- 28 Mar 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I haven't decided yet.
Publications
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Skeletal Muscle Mass Index Values in the Turkish Population Using Dual Energy X-Ray Absorptiometry
- ClinicalTrials.gov ID
- NCT07510009
- Acronym / sponsor ID
- ACHBİLKENTAUBAYKUT003
- Conditions
- Sarcopenia, Sarcopenia in Elderly
- Keywords
- sarcopenia, sarcopenia in elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
When low muscle strength is detected, the patient is evaluated for possible sarcopenia; the diagnosis is confirmed by the presence of low muscle mass or quality. Severe sarcopenia is considered when low muscle strength, low muscle mass or quality are accompanied by low physical performance. Muscle strength can be assessed by measuring hand grip strength and isometric or isokinetic measurements of lower extremity strength. A wide variety of techniques are used to measure muscle mass, including magnetic resonance imaging (MRI), computed tomography (CT), dual-energy x-ray absorptiometry (DEXA), bioelectrical impedance analysis (BIA), and anthropometric measurements; the most suitable method should be determined based on cost, accessibility, and ease of use. Muscle mass is related to body size; that is, individuals with larger body sizes typically have greater muscle mass. Therefore, to adjust for body size, the skeletal muscle index (SMI) is calculated as appendicular skeletal muscle mass (ALM) / height² (m²). The SMI cut-off value for sarcopenia, as defined by EWGSOP2, is <5.5 kg/m² for women and <7.0 kg/m² for men. There is ongoing debate regarding the preferred adjustment and whether the same method can be used for all populations. Physical performance assessment can be measured in various ways, including walking speed, the Short Physical Performance Battery (SPPB), and the Timed Up and Go Test (TUG).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| young population | – | –Ages 18-39 |
| elderly population | – | –Ages 65-99 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- city hospital
Key inclusion criteria (3 listed)
- Having mental and physical capacity
- Being between 18-39 and 65-99 years of age
- Being able to ambulate independently or with support
Key exclusion criteria (11 listed)
- Pregnancy
- Infection
- Pacemaker or metallic implant
- Peripheral circulatory disorder
- Known concomitant malignancy, end-stage organ failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
skeletal muscle mass index
Time frame: At the start of the work
Skeletal muscle mass index: calculated by dividing the sum of the non-bone lean mass of the four extremities by height² (meters).
4 secondary outcomes
muscle strength
Time frame: at the start of the work
walking speed test
Time frame: at the start of the work
Calf circumference
Time frame: at the start of the work
Mid-arm circumference
Time frame: at the start of the work
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Results publication: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Individual participant dataSharing planned: Undecided. I haven't decided yet.
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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.
Ayşe U Baykut principal investigator
Ankara City Hospital Bilkent
Güldal F Yüzer Nakipoğlu study chair
Ankara City Hospital Bilkent
Zeynep S Güneş study chair
Ankara City Hospital Bilkent
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 Sarcopenia and Sarcopenia in Elderly, run by Ankara City Hospital Bilkent 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 3 inclusion and 11 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 17 Jun 2026. 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?
skeletal muscle mass index (time frame: At the start of the work). 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 NCT07510009, 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 17 Jun 2026.