Prediabetic StateNCT03823664
Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals
An observational study of Prediabetic State and Diabetes Mellitus, Type 2, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetic State, Diabetes Mellitus, Type 2, Cardiorespiratory Fitness
- What is being tested?
- Cardiorespiratory Fitness
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 25 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Type 2 diabetic patients -> Type 2 diabetes diagnosed population, Prediabetic -> According to ADA criteria persons in prediabetic condition Healthy
Who may be able to join
- Cooperation,
- No assistance for Ambulation,
- Body Mass Index<40
- Diagnose of prediabetes/type 2 diabetes and health
Who cannot join
- Any cardiac problems,
- Uncontrolled hypertension,
- Any neurologic disease,
- Uncontrolled diabetes,
- Any orthopedic disease impairs walking, balance
- Any respiratory disease affects cardiorespiratory fitness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Cardiorespiratory Fitness
- Keywords
- prediabetes, type 2 diabetes, cardiorespiratory fitness, pulmonary functions, functional capacity, exercise capacity
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiorespiratory FitnessDiagnostic test
Also called Exercise capacity, Pulmonary function
Maximal symptom limited cardiopulmonary exercise test used assessment of cardiorespiratory fitness. For pulmonary function spirometry test and maximal respiratory pressures assessed.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Diagnostic Test: Cardiorespiratory Fitness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: November 2018-August 2019
Secondary outcomes (7)
Functional Exercise Capacity
6 Minutes Walk Test's distance, meters
Measured: December 2018-August 2019
Pulmonary functions
Forced expiratory volume in first second (FEV1)
Measured: December 2018-August 209
Respiratory Muscle Strength
Mouth pressures; maximal inspiratory and expiratory pressure
Measured: December 2018-August 2019
Maximal Exercise Capacity
İncremental Shuttle Walk Test
Measured: December 2018-August 2019
Physical Activity Level
Accelerometer
Measured: December 2018-August 2019
Pulmonary functions
Forced vital capacity (FVC)
Measured: December 2018-August 2019
Pulmonary functions
Peak expiratory flow (PEF)
Measured: December 2018-August 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Nov 2018
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Karadüz, Hacettepe University
- Investigators
- Ebru Calik-Kutukcu, PhD, Study director, Hacettepe UniversityHulya Arikan, Professor, Study chair, Hacettepe UniversityCemile Bozdemir-Ozel, MsC, Study chair, Hacettepe UniversitySelcuk Dagdelen, Professor, Study chair, Hacettepe UniversityBeyza Nur Karaduz, PT, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823664
- Sponsor's protocol ID
- GO 17/793
- Status last verified
- Jun 2020
- First submitted
- 8 Dec 2018
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Cardiorespiratory Fitness in Prediabetic,Type 2 Diabetic and Healthy Individuals
- ClinicalTrials.gov ID
- NCT03823664
- Acronym / sponsor ID
- GO 17/793
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetic | – | Diagnostic Test: Cardiorespiratory FitnessFasting 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 | – | Diagnostic Test: Cardiorespiratory FitnessFasting 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 | – | Diagnostic Test: Cardiorespiratory FitnessHealthy glucose metabolism and according to endocrinology visit no health problems related or affect cardiorespiratory fitness and other parameters examined in this study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetic patients -> Type 2 diabetes diagnosed population, Prediabetic -> According to ADA criteria persons in prediabetic condition Healthy
Key inclusion criteria (4 listed)
- Cooperation,
- No assistance for Ambulation,
- Body Mass Index<40
- Diagnose of prediabetes/type 2 diabetes and health
Key exclusion criteria (6 listed)
- Any cardiac problems,
- Uncontrolled hypertension,
- Any neurologic disease,
- Uncontrolled diabetes,
- Any orthopedic disease impairs walking, balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiorespiratory FitnessAlso: Exercise capacity, Pulmonary functionMaximal symptom limited cardiopulmonary exercise test used assessment of cardiorespiratory fitness. For pulmonary function spirometry test and maximal respiratory pressures assessed. | Diagnostic test | Healthy, Prediabetic, Type 2 Diabetic |
Primary outcome
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
7 secondary outcomes
Functional Exercise Capacity
Time frame: December 2018-August 2019
Pulmonary functions
Time frame: December 2018-August 209
Respiratory Muscle Strength
Time frame: December 2018-August 2019
Maximal Exercise Capacity
Time frame: December 2018-August 2019
Physical Activity Level
Time frame: December 2018-August 2019
Pulmonary functions
Time frame: December 2018-August 2019
Pulmonary functions
Time frame: December 2018-August 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Calik-Kutukcu, PhD study director
Hacettepe University
Hulya Arikan, Professor study chair
Hacettepe University
Cemile Bozdemir-Ozel, MsC study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prediabetic State and Diabetes Mellitus, Type 2, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (time frame: November 2018-August 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.