Respiratory Muscle Strength, Pulmonary Function, and Post-Exercise Recovery Responses According to Insulin Use in Individuals With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Maximal Inspiratory Pressure (MIP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
结局指标
主要结局
Maximal Inspiratory Pressure (MIP)
时间窗: 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.
次要结局
- 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)
- Blood Pressure Response and Recovery After the 6-Minute Walk Test(Pre-Test; Immediately Post-Test; 5 Minutes Post-Test)
- Forced Expiratory Volume in 1 Second (FEV1)(Single Visit (Baseline))
- FEV1/FVC Ratio(Single Visit (Baseline))
- Peak Expiratory Flow (PEF)(Single Visit (Baseline))
- Rating of Perceived Dyspnea During Recovery (Modified Borg Dyspnea Scale, 0-10)(Pre-Test; Immediately Post-Test; 5 Minutes Post-Test)
研究者
AYŞE KAYALI VATANSEVER
Assistant Professor
Izmir Bakircay University