Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: Cardiorespiratory Fitness


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 Diabetic<br>Fasting Plasma Glucose ≥126 mg/dL (7.0 mmol/L). OR * A1C ≥6.5% (48 mmol/mol). OR * Patients with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L).OR* 2-h Plasma Glucose ≥200 mg/dL (11.1 mmol/L) during oral glucose tolerance test* * American Diabetes As. (ADA) type 2 diabetes diagnosis criteria | Diagnostic Test: Cardiorespiratory Fitness<br>* Maximal symptom limited cardiopulmonary exercise test used assessment of cardiorespiratory fitness. For pulmonary function spirometry test and maximal respiratory pressures assessed.<br>* Other names: Pulmonary function;|
| Prediabetic<br>Fasting Plasma Glucose 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (Impaired Fasting Glucose)* OR A1C 5.7-6.4% (39-47 mmol/mol)* OR 2-h Plasma Glucose during 75-g Oral Glucose Tolerance Test 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (Impaired Glucose Tolerance)* * ADA prediabetes criteria | Diagnostic Test: Cardiorespiratory Fitness<br>* Maximal symptom limited cardiopulmonary exercise test used assessment of cardiorespiratory fitness. For pulmonary function spirometry test and maximal respiratory pressures assessed.<br>* Other names: Pulmonary function;|
| Healthy<br>Healthy glucose metabolism and according to endocrinology visit no health problems related or affect cardiorespiratory fitness and other parameters examined in this study. | Diagnostic Test: Cardiorespiratory Fitness<br>* Maximal symptom limited cardiopulmonary exercise test used assessment of cardiorespiratory fitness. For pulmonary function spirometry test and maximal respiratory pressures assessed.<br>* Other names: Pulmonary function;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Exercise Capacity | 6 Minutes Walk Test's distance, meters | December 2018-August 2019 | 
| Pulmonary functions | Forced expiratory volume in first second (FEV1) | December 2018-August 209 | 
| Respiratory Muscle Strength | Mouth pressures; maximal inspiratory and expiratory pressure | December 2018-August 2019 | 
| Maximal Exercise Capacity | İncremental Shuttle Walk Test | December 2018-August 2019 | 
| Physical Activity Level | Accelerometer | December 2018-August 2019 | 
| Pulmonary functions | Forced vital capacity (FVC) | December 2018-August 2019 | 
| Pulmonary functions | Peak expiratory flow (PEF) | December 2018-August 2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prediabetes, type 2 diabetes, cardiorespiratory fitness, pulmonary functions, functional capacity, exercise capacity