ClinicalTrials.gg
Not yet recruitingNCT07905274Updated Oct 29, 2026

Sarcopenia Risk in Obese T2DM Patients

An observational study in Sarcopenia and Obesity Type 2 Diabetes Mellitus, sponsored by Bandırma Onyedi Eylül University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Bandırma Onyedi Eylül University · Observational

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study aims to measure handgrip strength, walking speed, and the risk of muscle wasting in obese patients who have had diabetes for 5 years or longer, and to evaluate the relationship of these measures with factors that may influence them, such as the duration of diabetes, blood test results, body mass index, and the waist-to-height ratio.

02

Conditions studied

  • Sarcopenia
  • Obesity Type 2 Diabetes Mellitus

Keywords

  • obesity
  • diabetes mellitus
  • sarcopenia
  • muscle strength
03

In context

Sarcopenia

1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.

This study's planned enrollment of 150 is above the median of 120 across 455 observational studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Bandırma Onyedi Eylül University is the lead sponsor of 70 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

obese patients with type 2 diabetes mellitus

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being between 18 and 75 years of age.
  • Having a diagnosis of Type 2 diabetes mellitus for ≥ 5 years.
  • Having a ≥ 30 kg/m².
  • Being willing to participate in the study and providing written .

Exclusion criteria

Exclusion Criteria:

  • Having type 1 diabetes mellitus or other specific types of diabetes.
  • Having undergone a major surgical procedure within the last 6 months.
  • Having a diagnosis of and currently receiving oncological treatment.
  • Having a neuromuscular disorder (such as stroke, paraplegia, tetraplegia, myopathy, muscular dystrophy, amyotrophic lateral sclerosis, Parkinson's disease, etc.) that could significantly affect muscle strength or walking performance.
  • Being unable to complete the tests due to a lower-extremity amputation or an orthopedic condition.
  • Having an acute infection or an acute systemic illness requiring hospitalization.
  • Pregnancy.
  • Having a cognitive impairment or a psychiatric condition that hinders communication.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • obese patients with type 2 diabetes mellitus

    This study is designed as a cross-sectional, descriptive research project. Participants will include patients presenting to the internal medicine outpatient clinic who have a diagnosis of Type 2 diabetes mellitus (T2DM) for a duration of 5 years or longer and a body mass index (BMI) greater than 30 kg/m². Given that hyperglycemia and the metabolic/microvascular consequences of diabetes can have a cumulative effect on muscle mass and quality over time, a duration of \>5 years since the T2DM diagnosis is proposed as a screening/risk criterion for sarcopenia. Patients who meet the inclusion criteria and consent to participate will be referred to the Department of Physical Medicine and Rehabilitation for assessment of muscle strength, gait speed, and sarcopenia risk. Handgrip strength, the 5-times-sit-to-stand test, and the 4-meter walk test will be conducted by a physiatrist (specialist in Physical Medicine and Rehabilitation) and a physiotherapist, following a standardized protocol.

    Other: physical examination

Interventions

  • Otherphysical examination

    Sarcopenia assessment: The SARC-F questionnaire is a screening tool developed by Malmstrom and Morley in 2013, used to assess sarcopenia in older adults. This scale evaluates difficulties experienced by older individuals across five components: strength, assistance with walking, rising from a chair or bed, climbing stairs, and falls. Each item is scored on a scale of 0-2 (0: none, 1: some, 2: a lot). For the item regarding falls, however, the scoring is as follows: 0: none, 1: one to three times, and 2: four or more times. The total score on the scale ranges from 0 to 10. A score of four or higher indicates that an individual is at risk for sarcopenia. A study on the Turkish validity and reliability of the scale was conducted by Bahat et al. in 2018. Permission to use the scale was obtained from the corresponding author.

  • Otherphysical examination

    Handgrip strength: This is a measure used to assess muscle strength and serves as a primary criterion for probable sarcopenia, according to the EWGSOP2 (European Working Group on Sarcopenia in Older People 2) guidelines. Grip strength will be measured separately for each hand using a standard hand dynamometer (Baseline brand, 200 lb LITE hydraulic hand dynamometer). During the measurement, the participant will be seated with their shoulder in adduction and neutral rotation, the elbow flexed at approximately 90°, the forearm in a neutral position, and the wrist in slight extension. Three measurements will be taken for each hand, with short rest intervals between them; the mean of these measurements will be used for analysis.

  • Otherphysical examination

    Five-times-sit-to-stand test: This is a fundamental method for measuring muscle strength-assessing lower-extremity muscle strength, functional capacity, and fall risk-that serves as an alternative or a complement to handgrip strength, in accordance with EWGSOP2 criteria. The purpose of the test is to measure the strength and endurance of the lower-extremity (leg) muscles. The individual crosses their arms across their chest and stands up from-and sits back down on-a chair of standard height, without using their hands for assistance. The time required to complete five consecutive full sit-to-stand cycles is recorded in seconds using a stopwatch. According to the EWGSOP2 consensus, a duration of more than 15 seconds for these 5 repetitions is considered an indicator of low muscle strength (probable sarcopenia).

  • Otherphysical examination

    4-meter walking speed: The 4-meter walk test is a practical assessment used to gauge an individual's general health status, physical fitness, and the rate of biological aging. Speed is determined by dividing the 4-meter distance by the time taken to cover it, expressed in meters per second (m/s). During the test, the individual walks 4 meters along a flat path at a normal, comfortable pace, while the time elapsed is measured in seconds using a stopwatch. The calculation follows the formula: Speed = 4 ÷ Time Elapsed (in seconds). For instance, walking 4 meters in 4 seconds results in a speed of 1.0 m/s. Completing the 4-meter distance in more than 5 seconds (a speed below 0.8 m/s) is considered a slow walking pace and may indicate potential health risks-such as an increased risk of falls, muscle loss (sarcopenia), cognitive decline, or other general health issues. Speeds of 1.0 m/s or higher generally indicate a healthy and normal level of functional capacity.

06

What researchers measure

Primary outcomes

  1. risk of sarcopenia

    SARC-F survey. Scale Title: Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) Questionnaire. Score Range: 0-10 points. Interpretation: Higher scores indicate a higher risk of sarcopenia and greater severity of sarcopenia-related symptoms and functional limitations. A total score of 4 or higher indicates a positive screening result for sarcopenia risk.

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. muscle strength

    Hand grip strength Hand grip strength will be assessed using a hand dynamometer. Grip strength will be measured in kilograms (kg). Higher values indicate greater muscle strength, whereas lower values indicate reduced muscle strength and may be associated with an increased risk of sarcopenia.

    Time frame: through study completion, an average of 1 year

  2. lower-extremity strength, functional capacity, and fall risk

    Five-times sit-to-stand test Description: The Five-Times Sit-to-Stand Test (5xSTS) will be used to assess lower extremity muscle strength and functional performance. Participants will be instructed to stand up from a seated position and sit down five consecutive times as quickly as possible, with their arms crossed over their chest, without using their arms for support. The time required to complete all five repetitions will be recorded in seconds. Interpretation: Shorter completion times indicate better lower extremity muscle strength and functional performance, whereas longer completion times indicate poorer functional performance and may be associated with an increased risk of sarcopenia.

    Time frame: through study completion, an average of 1 year

  3. general health status, physical condition

    The 4-meter walk test Description: The 4-Meter Walk Test (4MWT) will be used to assess usual gait speed as an indicator of physical performance. Participants will be instructed to walk a 4-meter distance at their usual comfortable walking speed. The time required to complete the distance will be recorded in seconds, and gait speed will be calculated in meters per second (m/s) by dividing the distance walked by the completion time. Interpretation: Higher gait speed values indicate better physical performance, whereas lower gait speed values indicate poorer physical performance and may be associated with an increased risk of sarcopenia.

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
08

References and documents

Publications

  • Mesinovic J, Zengin A, De Courten B, Ebeling PR, Scott D. Sarcopenia and type 2 diabetes mellitus: a bidirectional relationship. Diabetes Metab Syndr Obes. 2019 Jul 8;12:1057-1072. doi: 10.2147/DMSO.S186600. eCollection 2019. PubMed 31372016 ↗
  • 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 ↗

Individual participant data

Plan to share: No — Once the study is completed, and provided that it passes the peer-review process and is accepted for publication as an article, researchers will be able to access the findings through the journal in which it is published.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Mar 2027, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2026
First posted
Oct 29, 2026
StartEst.
Oct 20, 2026
Primary completionEst.
Mar 20, 2027
CompletionEst.
Apr 20, 2027
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07905274
Lead sponsor
Bandırma Onyedi Eylül University
Responsible party
Nurten NAS KIRDAR (assistant professor, Bandırma Onyedi Eylül University) — Principal investigator
First posted
Oct 29, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Mar 20, 2027 (estimated)
Completion
Apr 20, 2027 (estimated)
Last update
Oct 29, 2026

Study contacts

Nurten NAS KIRDAR
Contact
nrtnns@gmail.com
+905415511691
Duygu KESEBİ İSGANDAROV
Contact
dkesebi@bandirma.edu.tr
Nurten NAS KIRDAR
principal investigator · Bandırma Onyedi Eylül University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion