Type 2 Diabetes Mellitus (T2DM)NCT06602778
Physical Activity Level and Sleep Quality in Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus (T2DM) and Sleep, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we investigated the effects of physical activity level and sleep quality level on total antioxidant level (TAS), total oxidant level (TOS), Malondialdehyde (MDA) and Superoxide Dismutase (SOD) which are markers of oxidative stress, irisin, fibronectin type III-protein 5 (FNDC5). Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Sleep, Biomarkers / Blood
- What is being tested?
- Biomarkers / blood and Questionnaire
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2024to 25 Feb 2025
- How long will I take part?
- 1 Day
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients applying to the endocrinology department at the medical faculty hospital
Who may be able to join
- Being between 30-65 years old
- Volunteering to participate in the study
- Being literate
- Being diagnosed with Type 2 Diabetes
Who cannot join
- Having a physical or mental illness that prevents communication
- malignant disease,
- infectious disease,
- chronic obstructive pulmonary disease,
- liver disease,
- patients with kidney disease and joint or muscle disease will not be included
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Physical Activity Level and Sleep Quality with Oxidative Stress and Exercise-related Biomarker Levels in Type 2 Diabetes
In this study, we investigated the effects of physical activity level and sleep quality level on total antioxidant level (TAS), total oxidant level (TOS), Malondialdehyde (MDA) and Superoxide Dismutase (SOD) which are markers of oxidative stress, irisin, fibronectin type III-protein 5 (FNDC5).
- Being tested
- Biomarkers / blood, Questionnaire
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers / bloodOther
Analysis of routine biochemical parameters
QuestionnaireOther
Physical activity level will be assessed using the International Physical Activity Questionnaire Short Form (IPQI) and sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The data to be obtained from blood will be obtained by selecting blood samples that will be sent to biological waste.
| Study group | Role | What they receive |
|---|---|---|
| T2DM-BMI0 | Not described Receives: Other: Biomarkers / blood; Other: Questionnaire | |
| T2DM-BMI1 | Not described Receives: Other: Biomarkers / blood; Other: Questionnaire | |
| T2DM-BMI2 | Not described Receives: Other: Biomarkers / blood; Other: Questionnaire | |
| T2DM-BMI3 | Not described Receives: Other: Biomarkers / blood; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
biomarkers derived from blood sera
blood glucose, total cholesterol, triglycerides, LDL and HDL analyzes
Measured: 10 Minutes
ELISA method of oxidative stress markers
All reagents of the ELISA kits of the oxidative stress markers TAS, TOS, MDA and SOD will be brought to room temperature. Standards will be prepared according to the protocol and added to a 96-well plate with the samples. Buffer solution will be added to each well and incubated for 90 min at room temperature. After each step, necessary washes will be performed and finally chromogenic agents will be added and read spectrophotometrically. Although the timing and additions may vary according to the parameter, in general the procedure is as indicated. Each sample will be run 2 times for both TAS and TOS
Measured: 10 minutes
Analysis of exercise-related markers by ELISA method
Measured: 10 minutes
International Physical Activity Questionnaire
Measured: 5 minutes
Pittsburgh Sleep Quality Index
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2024
- Primary completion20 Oct 2024
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Cihan, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602778
- Sponsor's protocol ID
- 2024/09.17
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Physical Activity Level and Sleep Quality with Oxidative Stress and Exercise-related Biomarker Levels in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06602778
- Acronym / sponsor ID
- 2024/09.17
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 19 Sep 2024 (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.
In this study, we investigated the effects of physical activity level and sleep quality level on total antioxidant level (TAS), total oxidant level (TOS), Malondialdehyde (MDA) and Superoxide Dismutase (SOD) which are markers of oxidative stress, irisin, fibronectin type III-protein 5 (FNDC5).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T2DM-BMI0 | – | Other: Biomarkers / blood, Other: Questionnaire |
| T2DM-BMI1 | – | Other: Biomarkers / blood, Other: Questionnaire |
| T2DM-BMI2 | – | Other: Biomarkers / blood, Other: Questionnaire |
| T2DM-BMI3 | – | Other: Biomarkers / blood, Other: Questionnaire |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients applying to the endocrinology department at the medical faculty hospital
Key inclusion criteria (4 listed)
- Being between 30-65 years old
- Volunteering to participate in the study
- Being literate
- Being diagnosed with Type 2 Diabetes
Key exclusion criteria (6 listed)
- Having a physical or mental illness that prevents communication
- malignant disease,
- infectious disease,
- chronic obstructive pulmonary disease,
- liver disease,
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 |
|---|---|---|
| Biomarkers / bloodAnalysis of routine biochemical parameters | Other | T2DM-BMI0, T2DM-BMI1, T2DM-BMI2, T2DM-BMI3 |
| QuestionnairePhysical activity level will be assessed using the International Physical Activity Questionnaire Short Form (IPQI) and sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The data to be obtained from blood will be obtained by selecting blood samples that will be sent to biological waste. | Other | T2DM-BMI0, T2DM-BMI1, T2DM-BMI2, T2DM-BMI3 |
Primary outcome
biomarkers derived from blood sera
Time frame: 10 Minutes
blood glucose, total cholesterol, triglycerides, LDL and HDL analyzes
ELISA method of oxidative stress markers
Time frame: 10 minutes
All reagents of the ELISA kits of the oxidative stress markers TAS, TOS, MDA and SOD will be brought to room temperature. Standards will be prepared according to the protocol and added to a 96-well plate with the samples. Buffer solution will be added to each well and incubated for 90 min at room temperature. After each step, necessary washes will be performed and finally chromogenic agents will be added and read spectrophotometrically. Although the timing and additions may vary according to the parameter, in general the procedure is as indicated. Each sample will be run 2 times for both TAS and TOS
Analysis of exercise-related markers by ELISA method
Time frame: 10 minutes
International Physical Activity Questionnaire
Time frame: 5 minutes
Pittsburgh Sleep Quality Index
Time frame: 5 minutes
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 19 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Type 2 Diabetes Mellitus (T2DM) and Sleep, run by Selcuk 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 19 Mar 2025. 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?
biomarkers derived from blood sera (time frame: 10 Minutes). The study lists 5 primary outcomes in all. 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 19 Mar 2025.