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Investigation of Chronotropic Index, Exercise Capacity in Type 1 Diabetes Mellitus

Investigation of Chronotropic Response, Exercise Capacity, Quality of Life, Peripheral and Respiratory Muscle Strength in Patients With Type 1 Diabetes Mellitus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04819815
Enrollment
54
Registered
2021-03-29
Start date
2020-01-20
Completion date
2021-09-30
Last updated
2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes mellitus, Chronotropic index, Exercise Capacity, Pulmonary Function

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.

Interventions

None listed

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Exercise CapacityFirst DayThe 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.
Chronotropic indexFirst DayThe chronotropic index will be calculated using the results of the maximal exercise test.

Secondary

MeasureTime frameDescription
Pulmonary function (FEV1 / FVC)First DayPulmonary 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.
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))First DayPulmonary 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.
Pulmonary function (Peak flow rate (PEF))First DayPulmonary 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, peak flow rate (PEF) will be evaluated.
Respiratory Muscle StrengthSecond DayMaximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.
Respiratory Muscle EnduranceSecond DayRespiratory muscle endurance will be assessed by the POWERbreathe Wellness (POWERbreathe, Inspiratory Muscle Training (IMT) Technologies Ltd. Birmingham, UK) device and the respiratory muscle endurance test at increased threshold load. The test will be started with 20% of the maximal inspiratory pressure and the pressure will be increased to 40%, 60%, 80%, and 100% every two minutes. Patients will be asked to continue breathing through the device during the test. During the test, the number of breaths delivered during each 2-minute period will be recorded. If the individual cannot breathe 3 consecutive times, the test will be terminated by the physiotherapist. The total duration of the test and the maximum pressure value at which it continues to breathe for at least 1 minute will be multiplied. The value found will be recorded as the respiratory muscle endurance value.
Pulmonary function (Forced vital capacity (FVC))First DayPulmonary 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.
Physical Activity LevelSecond DayPhysical activity will be evaluated multi sensor activity monitor.
Shortness of breathFirst DayThe Modified Medical Research Council (MMRC) dyspnea scale will be used to determine dyspnea perception during daily living activities. Dyspnea is graded as: zero (shortness of breath with strenuous exercise only); one (shortness of breath when rushing or walking up a slight uphill); two (because of shortness of breath they walk slower than people of the same age or have to stop to breathe while walking at their own pace); three (stops to breathe after walking 100 meters or after a few minutes); and four (too short of breath to leave the house or shortness of breath when getting dressed).
FatigueFirst DayFatigue will be evaluated using Turkish version of Fatigue Severity Scale. This questionnaire includes 9 items and score range for each item from 1 to 7 point (7-point Likert scale). Fatigue Severity Scale score is calculates by deriving an arithmetic mean. Cut-scores of over 4 are indicative of significant fatigue (higher scores show more severe fatigue).
Life QualityFirst DayIt will be evaluated by Turkish adaptation of the World Health Organization (WHO) well-being index.
Peripheral Muscle StrengthSecond DayKnee extensor muscle strength using portable hand held dynamometer will be evaluated.
Pulmonary function (Forced expiratory volume in the first second (FEV1))First DayPulmonary 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026