Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals

NCT03823664 | Completed

• 1 other identifier: GO 17/793
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

prediabetes; type 2 diabetes; cardiorespiratory fitness; pulmonary functions; functional capacity; exercise capacity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Functional Exercise Capacity

  December 2018-August 2019

• Pulmonary functions

  December 2018-August 209

• Respiratory Muscle Strength

  December 2018-August 2019

• Maximal Exercise Capacity

  December 2018-August 2019

• Physical Activity Level

  December 2018-August 2019

Study Arms (3)

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

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

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

Interventions

Cardiorespiratory Fitness DIAGNOSTIC_TEST

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

Also known as: Exercise capacity, Pulmonary function

Healthy; Prediabetic; Type 2 Diabetic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Cooperation,
• No assistance for Ambulation,
• Body Mass Index\<40
• Diagnose of prediabetes/type 2 diabetes and health

You may not qualify if:

• Any cardiac problems,
• Uncontrolled hypertension,
• Any neurologic disease,
• Uncontrolled diabetes,
• Any orthopedic disease impairs walking, balance
• Any respiratory disease affects cardiorespiratory fitness

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2; Inflammation

Interventions

Cardiorespiratory Fitness; Respiratory Function Tests

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Fitness; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health; Population Characteristics; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ebru Calik-Kutukcu, PhD

  Hacettepe University

  STUDY DIRECTOR

• Hulya Arikan, Professor

  Hacettepe University

  STUDY CHAIR

• Cemile Bozdemir-Ozel, MsC

  Hacettepe University

  STUDY CHAIR

• Selcuk Dagdelen, Professor

  Hacettepe University

  STUDY CHAIR

• Beyza Nur Karaduz, PT

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: December 8, 2018
• First Posted: January 30, 2019
• Study Start: November 1, 2018
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: June 29, 2020

Record last verified: 2020-06

Locations

TU (1)