Clinical trial NCT07002333: Investigation of Respiratory Muscle Sarcopenia in Adults Diagnosed With Diabetes
Official title: Investigation of Respiratory Muscle Sarcopenia in Adults Diagnosed With Diabetes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes
Diabetes Mellitus
Sarcopenia
Atrophy
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The sample size was calculated using G\*Power Software (ver. 3.1.3.2). A similar study in the literature was taken as a basis. The measurement values of the similar study were used to calculate the effect size (Effect size (d) = 0.12). Accordingly, the sample size of the study was found to be 84 participants with a 5% margin of error and 80% power.

Brief summary: The aim of this study was to investigate respiratory muscle sarcopenia in individuals with diabet. The main question it aims to answer is:

What is the prevalence of respiratory muscle sarcopenia in patients with diabet? Participants body composition (bioelectrical impedance), hand grip strength (hand dynanometer), physical performance tests (5 repetition sit-and-stand test, 4-meter walk test, 6 minute walk test, Timed up-and-go test) and respiratory muscle strength were evaluated.

Detailed description: The increase in the elderly population worldwide necessitates further research on age-related physiological changes and health problems related to these changes in geriatric individuals. One of these problems, sarcopenia, is a syndrome characterized by a decrease in muscle mass, muscle strength, and physical performance due to aging. Sarcopenia affects not only the extremity muscles but also the respiratory muscles, significantly reducing the individual's functional capacity and quality of life. Sarcopenia is a progressive and widespread loss of skeletal muscles, characterized by a decrease in muscle strength, muscle mass, and physical performance. Although it is usually seen in older individuals, it can also occur in people with certain diseases or who lead a sedentary lifestyle. The European Working Group on Sarcopenia in Older People (EWGSOP) has developed a guideline for the diagnosis of sarcopenia and determination of its severity. In line with this guideline, the EWGSOP considers sarcopenia in three basic stages: pre-sarcopenia, sarcopenia, and severe sarcopenia. Pre-sarcopenia is the stage in which muscle mass is low but muscle strength or physical performance is not yet affected. Sarcopenia is the stage in which low muscle mass is accompanied by decreased muscle strength or low physical performance. Severe sarcopenia is defined as the most advanced stage in which all these criteria are met. Respiratory muscle sarcopenia is defined as muscle fiber atrophy and weakness in the respiratory muscles. The Japanese Respiratory Sarcopenia Study Group defines this condition as whole-body sarcopenia with low respiratory muscle mass, decreased respiratory muscle strength, and/or respiratory dysfunction. Kera et al. (2019) evaluated respiratory muscle sarcopenia according to the peak expiratory flow rate value. However, whole-body sarcopenia and respiratory muscle strength are considered important parameters in the definition and diagnosis of respiratory muscle sarcopenia. It is reported that the rate of respiratory muscle sarcopenia is higher in the presence of sarcopenia. Sarcopenic respiratory failure is diagnosed in the presence of sarcopenia accompanied by functional disability, while individuals without functional disability but at risk for respiratory muscle sarcopenia are considered "at risk of sarcopenic respiratory failure". Sarcopenia is thought to be associated with insulin resistance and oxidative stress, leading to decreased muscle strength and muscle mass, as well as muscle atrophy. Respiratory muscles may also be affected in a similar way. Thus, weakening of respiratory muscles may lead to decreased respiratory function and decreased quality of life. In the current literature, studies examining the effects of aging on respiratory muscles are limited. Therefore, determining the potential effects of aging on respiratory muscles and evaluating respiratory muscle sarcopenia in this context may provide an important contribution to the development of new approaches and the literature.

Eligibility criteria: Inclusion Criteria:

* Age between 18-65
* Diagnosed with Type 2 Diabetes mellitus
* Being clinically stable
* Ability to adapt to tests (visual, cognitive, cooperative)

Exclusion Criteria:

* Those with neurological and/or musculoskeletal problems that may affect the study
* Presence of severe joint contracture or painful ulcers that may affect muscle strength measurement and walking
* Presence of serious infection or sepsis
* Having a known additional rheumatological disease diagnosis
* Any stage of cancer
* Pregnant or breastfeeding women

Primary outcomes:
measure: Respiratory Muscle Sarcopenia Assessment
timeFrame: Baseline
Secondary outcomes:
measure: Body composition
timeFrame: baseline
measure: Grip Force Measurement
timeFrame: baseline
measure: 5 Repetition Sit and Stand Test
timeFrame: baseline
measure: 4 Meter Walking Speed Test (4MWT)
timeFrame: baseline
measure: Timed Up and Go Test (TUG)
timeFrame: baseline
measure: Respiratory muscle strength
timeFrame: baseline
measure: 6 Minute Walk Test (6MWT):
timeFrame: baseline
measure: Age
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Educational status
timeFrame: Baseline
measure: Medication use
timeFrame: Baseline
Other outcomes:
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