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Type 1 Diabetes MellitusNCT04819815

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

An observational study of Type 1 Diabetes Mellitus, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate whether diabetes affects lung function and exercise capacity and impairs autonomic nervous system. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes Mellitus
How many people
54 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jan 2020to 30 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 27 patients with Type 1 Diabetes mellitus and 27 healthy individuals will be included.

Who may be able to join

  • 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
  • Willing to participate to the study
  • Between ages of 18 and 65

Who cannot join

  • 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
Show all 20Show fewer
  • 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
  • Body mass index> 30 kg / m²
  • Smoking exposure 10 pack×years
  • Individuals with any chronic illness

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

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

    Ankara, Çankaya, 06490

Other trials in Turkey (Türkiye)

About this study

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

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

Read the 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.

Keywords
Type 1 Diabetes mellitus, Chronotropic index, Exercise Capacity, Pulmonary Function
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04819815
Study groupRoleWhat they receive
Type 1 diabetes mellitusPatients 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 ControlsMaximal 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: First Day

  2. Chronotropic index

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

    Measured: First Day

Secondary outcomes (12)

  1. 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.

    Measured: First Day

  2. 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.

    Measured: First Day

  3. 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.

    Measured: First Day

  4. 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.

    Measured: First Day

  5. Pulmonary function (Peak flow rate (PEF))

    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.

    Measured: First Day

  6. Respiratory Muscle Strength

    Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.

    Measured: Second Day

  7. Respiratory Muscle Endurance

    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.

    Measured: Second Day

  8. Peripheral Muscle Strength

    Knee extensor muscle strength using portable hand held dynamometer will be evaluated.

    Measured: Second Day

  9. Physical Activity Level

    Physical activity will be evaluated multi sensor activity monitor.

    Measured: Second Day

  10. Shortness of breath

    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).

    Measured: First Day

  11. Fatigue

    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).

    Measured: First Day

  12. Life Quality

    It will be evaluated by Turkish adaptation of the World Health Organization (WHO) well-being index.

    Measured: First Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start20 Jan 2020
  3. Primary completion30 Jul 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04819815
Sponsor's protocol ID
Gazi University 26
Status last verified
Mar 2022
First submitted
25 Mar 2021
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26769183

  • 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.

    PubMed 16109070

  • Goldman MD. Lung dysfunction in diabetes. Diabetes Care. 2003 Jun;26(6):1915-8. doi: 10.2337/diacare.26.6.1915. No abstract available.

    PubMed 12766133

  • 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.

    PubMed 22271438

  • 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.

    PubMed 24508755

  • Sarisakaloglu A, Bosnak Guclu M, Coskun M, Balos Toruner F. Quality of life, physical activity levels, exercise capacity, and chronotropic incompetence in patients with type 1 diabetes mellitus. J Bodyw Mov Ther. 2026 Jun;46:49-57. doi: 10.1016/j.jbmt.2025.10.046. Epub 2025 Nov 1.

    PubMed 41927212

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes Mellitus, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise Capacity (time frame: First Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04819815, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.

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