Insulin Use and Respiratory Muscle Strength in Type 2 Diabetes

NCT07377448 | Completed

• 1 other identifier: 2468
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares breathing function, breathing muscle strength, and recovery after a walking test in adults with type 2 diabetes, based on whether they use insulin. People with type 2 diabetes will be evaluated during a single study visit at Izmir Bakircay University. Participants will be grouped as either currently using insulin or not using insulin as part of their usual diabetes treatment. All participants will complete the same tests: a breathing test (spirometry), breathing muscle strength tests (maximal inspiratory and expiratory pressures), and a 6-minute walk test. Before the walk test, immediately after the test, and 5 minutes after the test, recovery measures such as heart rate, oxygen saturation, blood pressure, and perceived shortness of breath and fatigue will be recorded. The goal is to understand whether insulin use is associated with differences in breathing and recovery responses in people with type 2 diabetes.

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 2 Treated With Insulin

Keywords

Insulin Therapy; Respiratory Muscle Strength; Maximal Inspiratory Pressure; Maximal Expiratory Pressure; Spirometry

Outcome Measures

Primary Outcomes (1)

• Maximal Inspiratory Pressure (MIP)

  Maximal inspiratory pressure (cmH2O) assessed using a respiratory pressure meter according to standardized respiratory muscle strength testing procedures. The best value from repeated acceptable maneuvers will be used for analysis.

  Single Visit (Baseline)

Secondary Outcomes (10)

• Maximal Expiratory Pressure (MEP)

  single Visit (Baseline)

• Spirometry Parameters (FVC) Forced Vital Capacity

  Single Visit (Baseline)

• 6-Minute Walk Distance (6MWD)

  Single Visit (During 6-Minute Walk Test)

• Heart Rate Response and Recovery After the 6-Minute Walk Test

  Pre-Test; Immediately Post-Test; 5 Minutes Post-Test

• Oxygen Saturation (SpO₂) Response and Recovery After the 6-Minute Walk Test

  Pre-Test; Immediately Post-Test; 5 Minutes Post-Test

Study Arms (2)

Insulin-Treated Type 2 Diabetes Mellitus

Participants with type 2 diabetes mellitus who are currently using insulin therapy as part of usual care at the time of assessment.

Non-Insulin-Treated Type 2 Diabetes Mellitus

Participants with type 2 diabetes mellitus who are not using insulin therapy as part of usual care at the time of assessment (e.g., lifestyle and/or oral antidiabetic agents).

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 40-70 years with a diagnosis of type 2 diabetes mellitus who attended the Izmir Bakircay University Physiotherapy and Rehabilitation Research and Practice Center and met the eligibility criteria. Participants were categorized as insulin-treated or non-insulin-treated based on current usual care.

You may qualify if:

• Age 40 to 70 years
• Diagnosis of type 2 diabetes mellitus for at least 1 year
• Receiving diabetes treatment (oral antidiabetic agents and/or insulin) for at least 6 months
• Stable metabolic status (HbA1c ≤ 10%)
• Independent ambulation
• Able to read and understand Turkish
• Provided written informed consent

You may not qualify if:

• Diagnosis of type 1 diabetes mellitus
• Active diabetic foot ulcer
• Acute respiratory tract infection or known chronic respiratory disease (e.g., COPD, asthma, interstitial lung disease)
• Cardiovascular disease history that may limit exercise testing (e.g., heart failure, uncontrolled hypertension, arrhythmia)
• Neurological disease, musculoskeletal problem, or balance disorder precluding participation in the exercise test
• Major surgery within the past 6 months
• Current cancer treatment or history of malignancy
• Cognitive impairment or psychiatric condition limiting cooperation
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Bakircay University

Izmir, İzmir, 35353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 30, 2026
• Study Start: January 2, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)