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NCT Number: NCT03823664

Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals

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.

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Key information

Conditions

Prediabetic State Cardiorespiratory Fitness Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Exercise Test Glucose Metabolism Disorders Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiorespiratory Fitness

Diagnostic Test

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

Other names: Exercise capacity, Pulmonary function

Primary outcomes

  1. Cardiorespiratory fitness

    Time frame: November 2018-August 2019

    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

Secondary outcomes

  1. Functional Exercise Capacity

    Time frame: December 2018-August 2019

    6 Minutes Walk Test's distance, meters

  2. Pulmonary functions

    Time frame: December 2018-August 209

    Forced expiratory volume in first second (FEV1)

  3. Respiratory Muscle Strength

    Time frame: December 2018-August 2019

    Mouth pressures; maximal inspiratory and expiratory pressure

  4. Maximal Exercise Capacity

    Time frame: December 2018-August 2019

    İncremental Shuttle Walk Test

  5. Physical Activity Level

    Time frame: December 2018-August 2019

    Accelerometer

  6. Pulmonary functions

    Time frame: December 2018-August 2019

    Forced vital capacity (FVC)

  7. Pulmonary functions

    Time frame: December 2018-August 2019

    Peak expiratory flow (PEF)

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2019
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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