Clinical trial NCT03823664: Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals
Official title: Assesment of Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prediabetic State
Diabetes Mellitus, Type 2
Cardiorespiratory Fitness
Inflammation
Exercise Test
Keywords: prediabetes
type 2 diabetes
cardiorespiratory fitness
pulmonary functions
functional capacity
exercise capacity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients -\> Type 2 diabetes diagnosed population, Prediabetic -\> According to ADA criteria persons in prediabetic condition Healthy

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiorespiratory fitness
timeFrame: November 2018-August 2019
Secondary outcomes:
measure: Functional Exercise Capacity
timeFrame: December 2018-August 2019
measure: Pulmonary functions
timeFrame: December 2018-August 209
measure: Respiratory Muscle Strength
timeFrame: December 2018-August 2019
measure: Maximal Exercise Capacity
timeFrame: December 2018-August 2019
measure: Physical Activity Level
timeFrame: December 2018-August 2019
measure: Pulmonary functions
timeFrame: December 2018-August 2019
measure: Pulmonary functions
timeFrame: December 2018-August 2019
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Ebru Calik-Kutukcu, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Hulya Arikan, Professor
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Cemile Bozdemir-Ozel, MsC
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Selcuk Dagdelen, Professor
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Beyza Nur Karaduz, PT
role: PRINCIPAL_INVESTIGATOR
References: