Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals

NCT ID: NCT03823664

Last Updated: 2020-06-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-06-25

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

Cardiorespiratory Fitness

Intervention Type: DIAGNOSTIC_TEST

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

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

Cardiorespiratory Fitness

Intervention Type: DIAGNOSTIC_TEST

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

Healthy

Healthy glucose metabolism and according to endocrinology visit no health problems related or affect cardiorespiratory fitness and other parameters examined in this study.

Cardiorespiratory Fitness

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Cardiorespiratory Fitness

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Exercise capacity; Pulmonary function

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Beyza Karadüz

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru Calik-Kutukcu, PhD

Role: STUDY_DIRECTOR

Hacettepe University

Hulya Arikan, Professor

Role: STUDY_CHAIR

Hacettepe University

Cemile Bozdemir-Ozel, MsC

Role: STUDY_CHAIR

Hacettepe University

Selcuk Dagdelen, Professor

Role: STUDY_CHAIR

Hacettepe University

Beyza Nur Karaduz, PT

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GO 17/793

Identifier Type: -

Identifier Source: org_study_id