Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Assesment of Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823664
• Other study ID #: GO 17/793
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cardiorespiratory Fitness
• Diabetes Mellitus, Type 2
• Exercise Test
• Inflammation
• Prediabetic State

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