NCT07905274|Not Yet Recruiting
Sarcopenia Risk in Obese T2DM Patients
Evaluation of Muscle Strength, Gait Speed, Sarcopenia Risk, and Associated Factors in Obese Patients With Type 2 Diabetes
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Evaluation of Muscle Strength, Gait Speed, Sarcopenia Risk, and Associated Factors in Obese Patients With Type 2 Diabetes
Sponsor study identifier
observational
150
1 country
1
Study Start
October 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 22, 2026
Actual (reported)October 29, 2026
Actual (reported)March 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
through study completion, an average of 1 year
muscle strength
through study completion, an average of 1 year
lower-extremity strength, functional capacity, and fall risk
through study completion, an average of 1 year
general health status, physical condition
through study completion, an average of 1 year
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.
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.
obese patients with type 2 diabetes mellitus
Bandırma Onyedi Eylul University Faculty of Medicine
Bandırma, Turkey (Türkiye)
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.
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.
Nurten NAS KIRDAR
Bandırma Onyedi Eylül University
First Submitted
October 22, 2026
First Posted
October 29, 2026
Study Start
October 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Frailty and Assocciated Factors in Sarcopenia
GLP-1 Receptor Agonist Use and Sarcopenia in Obese Individuals Without Diabetes
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.
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).
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.
Contact the study team to confirm eligibility.
March 20, 2027
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
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.
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