Clinical trial NCT04819815: Investigation of Chronotropic Index, Exercise Capacity in Type 1 Diabetes Mellitus
Official title: Investigation of Chronotropic Response, Exercise Capacity, Quality of Life, Peripheral and Respiratory Muscle Strength in Patients With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes mellitus
Chronotropic index
Exercise Capacity
Pulmonary Function
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 27 patients with Type 1 Diabetes mellitus and 27 healthy individuals will be included.

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Exercise Capacity
timeFrame: First Day
measure: Chronotropic index
timeFrame: First Day
Secondary outcomes:
measure: Pulmonary function (Forced vital capacity (FVC))
timeFrame: First Day
measure: Pulmonary function (Forced expiratory volume in the first second (FEV1))
timeFrame: First Day
measure: Pulmonary function (FEV1 / FVC)
timeFrame: First Day
measure: Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
timeFrame: First Day
measure: Pulmonary function (Peak flow rate (PEF))
timeFrame: First Day
measure: Respiratory Muscle Strength
timeFrame: Second Day
measure: Respiratory Muscle Endurance
timeFrame: Second Day
measure: Peripheral Muscle Strength
timeFrame: Second Day
measure: Physical Activity Level
timeFrame: Second Day
measure: Shortness of breath
timeFrame: First Day
measure: Fatigue
timeFrame: First Day
measure: Life Quality
timeFrame: First Day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
state: Çankaya
Study officials:
affiliation: Gazi Universitiy
name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Gazi Universitiy
name: Ayşenur SARISAKALOĞLU, Pt
role: STUDY_CHAIR
affiliation: Gazi Universitiy
name: Meriç COŞKUN, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi Universitiy
name: Füsun BALOŞ TÖRÜNER, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sydo N, Sydo T, Merkely B, Carta KG, Murphy JG, Lopez-Jimenez F, Allison TG. Impaired Heart Rate Response to Exercise in Diabetes and Its Long-term Significance. Mayo Clin Proc. 2016 Feb;91(2):157-65. doi: 10.1016/j.mayocp.2015.10.028. Epub 2016 Jan 5.
citation: Komatsu WR, Gabbay MA, Castro ML, Saraiva GL, Chacra AR, de Barros Neto TL, Dib SA. Aerobic exercise capacity in normal adolescents and those with type 1 diabetes mellitus. Pediatr Diabetes. 2005 Sep;6(3):145-9. doi: 10.1111/j.1399-543X.2005.00120.x.
citation: Goldman MD. Lung dysfunction in diabetes. Diabetes Care. 2003 Jun;26(6):1915-8. doi: 10.2337/diacare.26.6.1915. No abstract available.
citation: Fuso L, Pitocco D, Longobardi A, Zaccardi F, Contu C, Pozzuto C, Basso S, Varone F, Ghirlanda G, Antonelli Incalzi R. Reduced respiratory muscle strength and endurance in type 2 diabetes mellitus. Diabetes Metab Res Rev. 2012 May;28(4):370-5. doi: 10.1002/dmrr.2284.
citation: Miculis CP, De Campos W, da Silva Boguszweski MC. Correlation between glycemic control and physical activity level in adolescents and children with type 1 diabetes. J Phys Act Health. 2015 Feb;12(2):232-7. doi: 10.1123/jpah.2013-0024. Epub 2014 Feb 5.