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Not yet recruiting NCT07002333

Investigation of Respiratory Muscle Sarcopenia in Adults Diagnosed With Diabetes

Observational Diabetes Diabetes Mellitus Sarcopenia Atrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Diabetes, Diabetes Mellitus, Sarcopenia, Atrophy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Respiratory Muscle Sarcopenia Assessment [Time frame: Baseline]
Secondary outcome measures (12)
  • Body composition [Time frame: baseline]
  • Grip Force Measurement [Time frame: baseline]
  • 5 Repetition Sit and Stand Test [Time frame: baseline]
  • 4 Meter Walking Speed Test (4MWT) [Time frame: baseline]
  • Timed Up and Go Test (TUG) [Time frame: baseline]
  • Respiratory muscle strength [Time frame: baseline]
  • 6 Minute Walk Test (6MWT): [Time frame: baseline]
  • Age [Time frame: Baseline]
  • Height [Time frame: Baseline]
  • Gender [Time frame: Baseline]
  • Educational status [Time frame: Baseline]
  • Medication use [Time frame: Baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07002333 · 2025-AEU-FTR-MK-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗