Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals

Assesment of 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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Diabetes Mellitus, Type 2; Prediabetic State; Cardiorespiratory Fitness; Exercise Test
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Type 2 diabetic patients -> Type 2 diabetes diagnosed population, Prediabetic -> According to ADA criteria persons in prediabetic condition Healthy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Chair: Cemile Bozdemir-Ozel, MsC, Hacettepe University; Study Chair: Selcuk Dagdelen, Professor, Hacettepe University; Principal Investigator: Beyza Nur Karaduz, PT, Hacettepe University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): June 25, 2020
• Study Completion (ACTUAL): June 25, 2020

Study Registration Dates

• First Submitted: December 8, 2018
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (ACTUAL): January 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: exercise capacity; type 2 diabetes; prediabetes; functional capacity; pulmonary functions; cardiorespiratory fitness
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation; Prediabetic State
• Other Study ID Numbers: GO 17/793

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No