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NCT Number: NCT07377448

Insulin Use and Respiratory Muscle Strength in Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Treated With Insulin Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bakircay University

Izmir, İzmir, 35353, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Maximal Inspiratory Pressure (MIP)

    Time frame: Single Visit (Baseline)

    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.

Secondary outcomes

  1. Maximal Expiratory Pressure (MEP)

    Time frame: single Visit (Baseline)

    Maximal expiratory pressure (cmH2O) assessed using a respiratory pressure meter. The best value from repeated acceptable maneuvers will be used.

  2. Spirometry Parameters (FVC) Forced Vital Capacity

    Time frame: Single Visit (Baseline)

    Pulmonary function measured by spirometry following standard procedures.

  3. 6-Minute Walk Distance (6MWD)

    Time frame: Single Visit (During 6-Minute Walk Test)

    Total distance walked in 6 minutes (meters) on a standardized 30-meter corridor using standardized instructions.

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

    Time frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test

    Heart rate (beats/min) recorded at the specified time points using pulse oximetry.

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

    Time frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test

    Peripheral oxygen saturation (SpO₂, %) recorded at the specified time points using pulse oximetry.

  6. Blood Pressure Response and Recovery After the 6-Minute Walk Test

    Time frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test

    Systolic and diastolic blood pressure (mmHg) measured in a seated position at the specified time points.

  7. Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Single Visit (Baseline)

    Pulmonary function measured by spirometry following standard procedures.

  8. FEV1/FVC Ratio

    Time frame: Single Visit (Baseline)

    Calculated from spirometry values following standard procedures.

  9. Peak Expiratory Flow (PEF)

    Time frame: Single Visit (Baseline)

    Pulmonary function measured by spirometry following standard procedures.

  10. Rating of Perceived Dyspnea During Recovery (Modified Borg Dyspnea Scale, 0-10)

    Time frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test

    Perceived dyspnea will be assessed using the Modified Borg Dyspnea Scale (0 = no breathlessness at all; 10 = maximal breathlessness). Higher scores indicate worse dyspnea.

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study title

Respiratory Muscle Strength, Pulmonary Function, and Post-Exercise Recovery Responses According to Insulin Use in Individuals With Type 2 Diabetes Mellitus

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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