An observational study in Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 2 Treated With Insulin, sponsored by Izmir Bakircay University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Izmir Bakircay University · Observational
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 70 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Izmir Bakircay University is the lead sponsor of 73 studies on the registry; 17 are open to participants now.
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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.
Exclusion Criteria:
Participants with type 2 diabetes mellitus who are currently using insulin therapy as part of usual care at the time of assessment.
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).
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.
Time frame: Single Visit (Baseline)
Maximal Expiratory Pressure (MEP)
Maximal expiratory pressure (cmH2O) assessed using a respiratory pressure meter. The best value from repeated acceptable maneuvers will be used.
Time frame: single Visit (Baseline)
Spirometry Parameters (FVC) Forced Vital Capacity
Pulmonary function measured by spirometry following standard procedures.
Time frame: Single Visit (Baseline)
6-Minute Walk Distance (6MWD)
Total distance walked in 6 minutes (meters) on a standardized 30-meter corridor using standardized instructions.
Time frame: Single Visit (During 6-Minute Walk Test)
Heart Rate Response and Recovery After the 6-Minute Walk Test
Heart rate (beats/min) recorded at the specified time points using pulse oximetry.
Time frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Oxygen Saturation (SpO₂) Response and Recovery After the 6-Minute Walk Test
Peripheral oxygen saturation (SpO₂, %) recorded at the specified time points using pulse oximetry.
Time frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Blood Pressure Response and Recovery After the 6-Minute Walk Test
Systolic and diastolic blood pressure (mmHg) measured in a seated position at the specified time points.
Time frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Forced Expiratory Volume in 1 Second (FEV1)
Pulmonary function measured by spirometry following standard procedures.
Time frame: Single Visit (Baseline)
FEV1/FVC Ratio
Calculated from spirometry values following standard procedures.
Time frame: Single Visit (Baseline)
Peak Expiratory Flow (PEF)
Pulmonary function measured by spirometry following standard procedures.
Time frame: Single Visit (Baseline)
Rating of Perceived Dyspnea During Recovery (Modified Borg Dyspnea Scale, 0-10)
Perceived dyspnea will be assessed using the Modified Borg Dyspnea Scale (0 = no breathlessness at all; 10 = maximal breathlessness). Higher scores indicate worse dyspnea.
Time frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Plan to share: No — De-identified individual participant data will not be shared
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Izmir Bakircay University