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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03823664
Other study ID # GO 17/793
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date June 25, 2020

Study information

Verified date June 2020
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study to investigate and compare cardiorespiratory fitness (CRF) parameters of prediabetic, type 2 diabetic and healthy individuals. CRF assessed with cardiopulmonary exercise test (CPET) which is gold standard measure of CRF. Pulmonary functions, inflammation, disease specific parameters such as HbA1c, fasting plasma glucose etc affect CRF in prediabetic and type 2 diabetics.All parameters examine in this study.


Description:

This study will be participated with Type 2 diabetic,prediabetic and healthy patients. Patients' laboratory values, pulmonary function test, respiratory muscle strength, exercise capacity, physical activity level, quality of life, cardiorespiratory fitness levels will assess and record. Pulmonary function test will be assesed with CPET system, respiratory muscle strength will be evaluated with mouth pressure. Exercise capacity will be evaluated using six minute walking test, incremental shuttle walk test. And cardiorespiratory fitness will assess CPET system. Physical activity level will be evaluated trial accelerometer and International Physical Activity Questionnaire.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date June 25, 2020
Est. primary completion date June 25, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Cooperation,

- No assistance for Ambulation,

- Body Mass Index<40

- Diagnose of prediabetes/type 2 diabetes and health

Exclusion Criteria:

- Any cardiac problems,

- Uncontrolled hypertension,

- Any neurologic disease,

- Uncontrolled diabetes,

- Any orthopedic disease impairs walking, balance

- Any respiratory disease affects cardiorespiratory fitness

Study Design


Intervention

Diagnostic Test:
Cardiorespiratory Fitness
Maximal symptom limited cardiopulmonary exercise test used assessment of cardiorespiratory fitness. For pulmonary function spirometry test and maximal respiratory pressures assessed.

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiorespiratory fitness Refers to the ability of the circulatory and respiratory systems to supply oxygen to skeletal muscles during sustained physical exercise. It will be evaluated with Cardiopulmonary Exercise Test (CPET,CPX) System November 2018-August 2019
Secondary Functional Exercise Capacity 6 Minutes Walk Test's distance, meters December 2018-August 2019
Secondary Pulmonary functions Forced expiratory volume in first second (FEV1) December 2018-August 209
Secondary Respiratory Muscle Strength Mouth pressures; maximal inspiratory and expiratory pressure December 2018-August 2019
Secondary Maximal Exercise Capacity Incremental Shuttle Walk Test December 2018-August 2019
Secondary Physical Activity Level Accelerometer December 2018-August 2019
Secondary Pulmonary functions Forced vital capacity (FVC) December 2018-August 2019
Secondary Pulmonary functions Peak expiratory flow (PEF) December 2018-August 2019
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