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

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ClinicalTrials.gov Identifier: NCT04819815
Recruitment Status : Recruiting
First Posted : March 29, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Meral Boşnak Güçlü, Gazi University

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

Condition or disease
Type 1 Diabetes Mellitus

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.

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Study Type : Observational
Estimated Enrollment : 54 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Investigation of Chronotropic Response, Exercise Capacity, Quality of Life, Peripheral and Respiratory Muscle Strength in Patients With Type 1 Diabetes Mellitus
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Type 1 diabetes mellitus

Patients

Maximal exercise capacity (Incremental shuttle walk test), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), peripheral muscle strength (dynamometer), respiratory muscle endurance ( incremental threshold loading test), physical activity level (multi sensor activity monitor), quality of life (World Health Organization (WHO) well-being index), fatigue (fatigue severity scale), shortness of breath (Modified Medical Research Council MMRC) will be evaluated.

Healthy Controls
Maximal exercise capacity (Incremental shuttle walk test), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), peripheral muscle strength (dynamometer), respiratory muscle endurance ( incremental threshold loading test), physical activity level (multi sensor activity monitor), quality of life (World Health Organization (WHO) well-being index), fatigue ( fatigue severity scale), shortness of breath (Modified Medical Research Council MMRC) will be evaluated.



Primary Outcome Measures :
  1. Exercise Capacity [ Time Frame: 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.

  2. Chronotropic index [ Time Frame: First Day ]
    The chronotropic index will be calculated using the results of the maximal exercise test.


Secondary Outcome Measures :
  1. Pulmonary function (Forced vital capacity (FVC)) [ Time Frame: First Day ]
    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.

  2. Pulmonary function (Forced expiratory volume in the first second (FEV1)) [ Time Frame: First Day ]
    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.

  3. Pulmonary function (FEV1 / FVC) [ Time Frame: First Day ]
    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.

  4. Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)) [ Time Frame: First Day ]
    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.

  5. Pulmonary function (Peak flow rate (PEF)) [ Time Frame: First Day ]
    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, peak flow rate (PEF) will be evaluated.

  6. Respiratory Muscle Strength [ Time Frame: Second Day ]
    Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.

  7. Respiratory Muscle Endurance [ Time Frame: Second Day ]

    Respiratory 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.


  8. Peripheral Muscle Strength [ Time Frame: Second Day ]
    Knee extensor muscle strength using portable hand held dynamometer will be evaluated.

  9. Physical Activity Level [ Time Frame: Second Day ]
    Physical activity will be evaluated multi sensor activity monitor.

  10. Shortness of breath [ Time Frame: First Day ]

    The 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).


  11. Fatigue [ Time Frame: First Day ]
    Fatigue 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).

  12. Life Quality [ Time Frame: First Day ]
    It will be evaluated by Turkish adaptation of the World Health Organization (WHO) well-being index.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
27 patients with Type 1 Diabetes mellitus and 27 healthy individuals will be included.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819815


Contacts
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Contact: Meral BOŞNAK GÜÇLÜ, Prof. Dr. +90312 216 2647 meralbosnak@gazi.edu.tr
Contact: Ayşenur SARISAKALOĞLU, Pt +90312 216 2647 eseraysenur@gmail.com

Locations
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Turkey
Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit Recruiting
Ankara, Çankaya, Turkey, 06490
Contact: Meral BOŞNAK GÜÇLÜ, Prof. Dr.    +90312 216 2647    meralbosnak@gazi.edu.tr   
Contact: Ayşenur SARISAKALOĞLU, Pt    +90312 216 2647    eseraysenur@gmail.com   
Sponsors and Collaborators
Gazi University
Investigators
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Study Director: Meral BOŞNAK GÜÇLÜ, Prof. Dr. Gazi Universitiy
Study Chair: Ayşenur SARISAKALOĞLU, Pt Gazi Universitiy
Principal Investigator: Meriç COŞKUN, Dr. Gazi Universitiy
Principal Investigator: Füsun BALOŞ TÖRÜNER, Prof.Dr. Gazi Universitiy
Publications:
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Responsible Party: Meral Boşnak Güçlü, Prof. Dr., Gazi University
ClinicalTrials.gov Identifier: NCT04819815    
Other Study ID Numbers: Gazi University 26
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meral Boşnak Güçlü, Gazi University:
Type 1 Diabetes mellitus
Chronotropic index
Exercise Capacity
Pulmonary Function
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases