NCT04819815 - Investigation of Chronotropic Index, Exercise Capacity in Type 1 Diabetes Mellitus | Crick

Overview

To investigate whether diabetes affects lung function and exercise capacity and impairs autonomic nervous system.

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. Physical activity level of individuals with type 1 diabetes will be evaluated using metabolic holter, which is an objective method. Patients and healthy individuals will be evaluated and compared. According to the sample size analysis, 27 patients and 27 healthy individuals with similar demographic characteristics will be included in the study. Evaluations will be completed within two days.

Study Type

OBSERVATIONAL

Enrollment

54

Conditions

Type 1 Diabetes Mellitus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 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 Exclusion Criteria: 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 * Anemia * 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

Locations (1)

Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, Çankaya, Turkey (Türkiye)

Outcomes

Primary Outcomes

Exercise Capacity

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.

Time frame: First Day

Chronotropic index

The chronotropic index will be calculated using the results of the maximal exercise test.

Time frame: First Day

Secondary Outcomes

Pulmonary function (Forced vital capacity (FVC))

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.

Time frame: First Day

Pulmonary function (Forced expiratory volume in the first second (FEV1))

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.

Time frame: First Day

Pulmonary function (FEV1 / FVC)

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.

Time frame: First Day

Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.