Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 2 Treated With Insulin
Conditions
Keywords
Insulin Therapy, Respiratory Muscle Strength, Maximal Inspiratory Pressure, Maximal Expiratory Pressure, Spirometry
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.
Interventions
None listed
Sponsors
Izmir Bakircay University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Inspiratory Pressure (MIP) | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximal Expiratory Pressure (MEP) | single Visit (Baseline) | Maximal expiratory pressure (cmH2O) assessed using a respiratory pressure meter. The best value from repeated acceptable maneuvers will be used. |
| Spirometry Parameters (FVC) Forced Vital Capacity | Single Visit (Baseline) | Pulmonary function measured by spirometry following standard procedures. |
| 6-Minute Walk Distance (6MWD) | Single Visit (During 6-Minute Walk Test) | Total distance walked in 6 minutes (meters) on a standardized 30-meter corridor using standardized instructions. |
| Heart Rate Response and Recovery After the 6-Minute Walk Test | Pre-Test; Immediately Post-Test; 5 Minutes Post-Test | Heart rate (beats/min) recorded at the specified time points using pulse oximetry. |
| Oxygen Saturation (SpO₂) Response and Recovery After the 6-Minute Walk Test | Pre-Test; Immediately Post-Test; 5 Minutes Post-Test | Peripheral oxygen saturation (SpO₂, %) recorded at the specified time points using pulse oximetry. |
| Blood Pressure Response and Recovery After the 6-Minute Walk Test | 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. |
| Forced Expiratory Volume in 1 Second (FEV1) | Single Visit (Baseline) | Pulmonary function measured by spirometry following standard procedures. |
| FEV1/FVC Ratio | Single Visit (Baseline) | Calculated from spirometry values following standard procedures. |
| Peak Expiratory Flow (PEF) | Single Visit (Baseline) | Pulmonary function measured by spirometry following standard procedures. |
| Rating of Perceived Dyspnea During Recovery (Modified Borg Dyspnea Scale, 0-10) | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed