Investigation of Chronotropic Response, Exercise Capacity, Quality of Life, Peripheral and Respiratory Muscle Strength in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Chronotropic index
研究概览
简要总结
To investigate whether diabetes affects lung function and exercise capacity and impairs autonomic nervous system.
详细描述
Type 1 diabetes mellitus is a systemic disease that affects the biochemical, morphological and functional properties of various tissues of the body. It is characterized by the loss of insulin-producing cells associated with an autoimmune disorder.
The chronotropic response is an increase in heart rate due to physical activity and metabolic demand. Chronotropic disorder is an inadequate cardiac response and is frequently encountered in individuals with diabetes. Diabetes-related comorbidities or physiological abnormalities may lead to impaired chronotropic response, such as altered blood catecholamine levels during exercise, structural myocardial anomalies, and impaired baroreflex sensitivity. While there are studies on chronotropic response in individuals with type 2 diabetes, chronotropic disorders have not been investigated in adults with type 1 diabetes.
Diabetes affects the lungs negatively. In individuals with diabetes decreased lung volume, and diffusion were observed. Dynamic lung capacity of individuals with type 1 diabetes with the pulmonary function test will be investigated.
There are limited studies evaluating respiratory muscle strength and endurance in individuals with type 1 diabetes. These studies have presented conflicting findings. Informations will be provided to literature by evaluating respiratory muscle strength and endurance.
Physical activity is positively correlated with in the cardiovascular risk factor. Hyperglycemia stresses or fear of hypoglycemia experienced by individuals with type 1 diabetes may lead people to a sedentary life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for patients group:
- •Individuals aged 18-65 years diagnosed with Type 1 diabetes by basic clinical and laboratory techniques
- •Individuals using pump and injection insulin to control type 1 diabetes
- •Inclusion criteria for healthy group:
- •Willing to participate to the study
- •Between ages of 18 and 65
排除标准
- •Exclusion criteria for patients group:
- •Individuals with body mass index> 30 kg / m²
- •those with lower limb amputation
- •those with any heart disease
- •Individuals with type 2 diabetes
- •Individuals who smoke 10 pack×years
- •Individuals with diabetic foot
- •Individuals with orthopedic problems
- •Individuals with balance problems
- •Myocardial infarction or other acute cardiac events within 2 days
- •Unstable angina
- •Uncontrolled heart rhythm causing symptoms or hemodynamic effects
- •Uncontrolled symptomatic heart failure
- •Acute pulmonary embolism or pulmonary infarction
- •Acute myocarditis or pericarditis
- •Suspected or known dissection aneurysm,
- •Having an acute systemic infection accompanied by fever, body aches or swollen lymph nodes
- •Exclusion criteria for healthy group:
- •Body mass index> 30 kg / m²
- •Smoking exposure 10 pack×years
- •Individuals with any chronic illness
结局指标
主要结局
Chronotropic index
时间窗: First Day
The chronotropic index will be calculated using the results of the maximal exercise test.
Exercise Capacity
时间窗: First Day
The maximal exercise capacity of the individuals will be evaluated by the incremental shuttle walk test. This test is a symptom-limited maximal field test that evaluates maximal exercise capacity with progressively increased walking speed.
次要结局
- Pulmonary function (Forced expiratory volume in the first second (FEV1))(First Day)
- Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))(First Day)
- Pulmonary function (Forced vital capacity (FVC))(First Day)
- Respiratory Muscle Endurance(Second Day)
- Pulmonary function (FEV1 / FVC)(First Day)
- Respiratory Muscle Strength(Second Day)
- Pulmonary function (Peak flow rate (PEF))(First Day)
- Peripheral Muscle Strength(Second Day)
- Shortness of breath(First Day)
- Fatigue(First Day)
- Physical Activity Level(Second Day)
- Life Quality(First Day)
研究者
Meral Boşnak Güçlü
Prof. Dr.
Gazi University