Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT03823664

Collaborator

(none)

Enrollment

Location

19.8

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prediabetic State Diabetes Mellitus, Type 2 Cardiorespiratory Fitness Inflammation Exercise Test	Diagnostic Test: Cardiorespiratory Fitness

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.

Study Design

Study Type:

Observational

Actual Enrollment :

48 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Jun 25, 2020

Actual Study Completion Date :

Jun 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Type 2 Diabetic 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 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
Prediabetic 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 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
Healthy 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 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

Arm

Intervention/Treatment

Type 2 Diabetic

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

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

Prediabetic

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

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

Healthy

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

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

Outcome Measures

Primary Outcome Measures

Cardiorespiratory fitness [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 Outcome Measures

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