- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06602778
Physical Activity Level and Sleep Quality in Type 2 Diabetes
March 15, 2025 updated by: Emine Cihan, Selcuk University
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
80
Phase
- Not Applicable
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
-
-
Selcuklu
-
Konya, Selcuklu, Turkey, 42130
- Selcuk 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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients applying to the endocrinology department at the medical faculty hospital
Description
Inclusion Criteria:
- Being between 30-65 years old
- Volunteering to participate in the study
- Being literate
- Being diagnosed with Type 2 Diabetes
Exclusion Criteria:
- 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
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 |
Intervention / Treatment |
|---|---|
|
T2DM-BMI0
|
Analysis of routine biochemical parameters
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.
|
|
T2DM-BMI1
|
Analysis of routine biochemical parameters
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.
|
|
T2DM-BMI2
|
Analysis of routine biochemical parameters
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.
|
|
T2DM-BMI3
|
Analysis of routine biochemical parameters
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
biomarkers derived from blood sera
Time Frame: 10 Minutes
|
blood glucose, total cholesterol, triglycerides, LDL and HDL analyzes
|
10 Minutes
|
|
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
|
10 minutes
|
|
Analysis of exercise-related markers by ELISA method
Time Frame: 10 minutes
|
10 minutes
|
|
|
International Physical Activity Questionnaire
Time Frame: 5 minutes
|
5 minutes
|
|
|
Pittsburgh Sleep Quality Index
Time Frame: 5 minutes
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 20, 2024
Primary Completion (Actual)
October 20, 2024
Study Completion (Actual)
February 25, 2025
Study Registration Dates
First Submitted
September 17, 2024
First Submitted That Met QC Criteria
September 17, 2024
First Posted (Actual)
September 19, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 15, 2025
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/09.17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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