Investigation of Respiratory Muscle Sarcopenia in Adults Diagnosed With Diabetes

NCT07002333 | Not Yet Recruiting

• 1 other identifier: 2025-AEU-FTR-MK-01
• Study Type: observational
• Target: 85
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes; Diabetes Mellitus; Sarcopenia; Atrophy

Outcome Measures

Primary Outcomes (1)

• Respiratory Muscle Sarcopenia Assessment

  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.

  Baseline

Secondary Outcomes (12)

• Body composition

  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

Study Arms (1)

Adults with Diabetes

Individuals diagnosed with Type 2 Diabetes mellitus between the ages of 18-65

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

MeSH Terms

Conditions

Diabetes Mellitus; Sarcopenia; Atrophy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Muhammed İhsan KODAK, PhD

CONTACT

05532333661; mihsankodak@ahievran.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: June 3, 2025
• Study Start: July 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share