Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals

June 26, 2020 updated by: Beyza Karadüz, Hacettepe University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiorespiratory fitness
Time Frame: 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
November 2018-August 2019

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Exercise Capacity
Time Frame: December 2018-August 2019
6 Minutes Walk Test's distance, meters
December 2018-August 2019
Pulmonary functions
Time Frame: December 2018-August 209
Forced expiratory volume in first second (FEV1)
December 2018-August 209
Respiratory Muscle Strength
Time Frame: December 2018-August 2019
Mouth pressures; maximal inspiratory and expiratory pressure
December 2018-August 2019
Maximal Exercise Capacity
Time Frame: December 2018-August 2019
İncremental Shuttle Walk Test
December 2018-August 2019
Physical Activity Level
Time Frame: December 2018-August 2019
Accelerometer
December 2018-August 2019
Pulmonary functions
Time Frame: December 2018-August 2019
Forced vital capacity (FVC)
December 2018-August 2019
Pulmonary functions
Time Frame: December 2018-August 2019
Peak expiratory flow (PEF)
December 2018-August 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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