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临床试验/NCT07002333
NCT07002333尚未招募不适用

Investigation of Respiratory Muscle Sarcopenia in Adults Diagnosed With Diabetes

Kirsehir Ahi Evran Universitesi0 个研究点目标入组 85 人开始时间: 2025年7月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
85
主要终点
Respiratory Muscle Sarcopenia Assessment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

结局指标

主要结局

Respiratory Muscle Sarcopenia Assessment

时间窗: Baseline

The diagnosis of respiratory muscle sarcopenia will also be made by combining the results of secondary measurements. Participants included in the study: Hand grip strength \<27 kg for men and \<16 kg for women, Bioelectrical Impedance Analysis (Skeletal muscle mass (SMM) \<20 kg for men and \<15 kg for women) the participant is diagnosed with sarcopenia. They will also be diagnosed with a frailty phenotype based on the results of the Timed Stand and Walk Test, the 4 meter walk test and the 5 Repetition Sit and Stand Test. Patients diagnosed with sarcopenia will be diagnosed with respiratory muscle sarcopenia if respiratory muscle weakness is also detected.

次要结局

  • Body composition(baseline)
  • Educational status(Baseline)
  • Grip Force Measurement(baseline)
  • 5 Repetition Sit and Stand Test(baseline)
  • 4 Meter Walking Speed Test (4MWT)(baseline)
  • Timed Up and Go Test (TUG)(baseline)
  • Respiratory muscle strength(baseline)
  • 6 Minute Walk Test (6MWT):(baseline)
  • Age(Baseline)
  • Height(Baseline)
  • Gender(Baseline)
  • Medication use(Baseline)

研究者

发起方
Kirsehir Ahi Evran Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed İhsan KODAK

assistant professor

Kirsehir Ahi Evran Universitesi

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