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

NCT04819815 | Completed

• 1 other identifier: Gazi University 26
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  First Day

• Chronotropic index

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

  First Day

Secondary Outcomes (12)

• Pulmonary function (Forced vital capacity (FVC))

  First Day

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

  First Day

• Pulmonary function (FEV1 / FVC)

  First Day

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

  First Day

• Pulmonary function (Peak flow rate (PEF))

  First Day

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 26769183 BACKGROUND

• 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.

  PMID: 16109070 BACKGROUND

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

  PMID: 12766133 BACKGROUND

• 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.

  PMID: 22271438 BACKGROUND

• 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.

  PMID: 24508755 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi Universitiy

  STUDY DIRECTOR

• Ayşenur SARISAKALOĞLU, Pt

  Gazi Universitiy

  STUDY CHAIR

• Meriç COŞKUN, Dr.

  Gazi Universitiy

  PRINCIPAL INVESTIGATOR

• Füsun BALOŞ TÖRÜNER, Prof.Dr.

  Gazi Universitiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: January 20, 2020
• Primary Completion: July 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)