Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals

Completed

• Conditions: Diabetes Mellitus, Type 2; Prediabetic State; Cardiorespiratory Fitness; Inflammation; Exercise Test
• Interventions: Diagnostic Test: Cardiorespiratory Fitness

• Registration Number: NCT03823664
• Lead Sponsor: Hacettepe University

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.

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2018-12-08
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-30
• Status Verified: 2020-06
• Primary Completion: 2020-06-25
• Study Completion: 2020-06-25
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 2 Diabetic	Cardiorespiratory Fitness	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
Prediabetic	Cardiorespiratory Fitness	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
Healthy	Cardiorespiratory Fitness	Healthy glucose metabolism and according to endocrinology visit no health problems related or affect cardiorespiratory fitness and other parameters examined in this study.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	Peak expiratory flow (PEF)
Functional Exercise Capacity	December 2018-August 2019	6 Minutes Walk Test's distance, meters

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey