Sarcopenia Risk in Obese T2DM Patients

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 75 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: obese patients with type 2 diabetes mellitus

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Evaluation of Muscle Strength, Gait Speed, Sarcopenia Risk, and Associated Factors in Obese Patients With Type 2 Diabetes

Conditions

Sarcopenia, Obesity Type 2 Diabetes Mellitus

Being tested

physical examination

Keywords

obesity, diabetes mellitus, sarcopenia, muscle strength

Medical subject headings

Sarcopenia, Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• physical examinationOther

  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.

• physical examinationOther

  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.

• physical examinationOther

  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).

• physical examinationOther

  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.

What is being measured

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

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.

   Measured: through study completion, an average of 1 year

Timeline

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

1. First posted29 Oct 2026
2. Study start20 Oct 2026 (estimated)
3. Primary completion20 Mar 2027 (estimated)
4. Study completion20 Apr 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (2)Papers the sponsor has linked to this study.
• Other trials for SarcopeniaStudies 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.