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Completed

NCT Number: NCT06602778

Physical Activity Level and Sleep Quality 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).

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Biomarkers / Blood Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Physical Activity Level Sleep

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University

Konya, Selcuklu, 42130, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biomarkers / blood

Other

Analysis of routine biochemical parameters

Questionnaire

Other

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.

Primary outcomes

  1. biomarkers derived from blood sera

    Time frame: 10 Minutes

    blood glucose, total cholesterol, triglycerides, LDL and HDL analyzes

  2. 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

  3. Analysis of exercise-related markers by ELISA method

    Time frame: 10 minutes

  4. International Physical Activity Questionnaire

    Time frame: 5 minutes

  5. Pittsburgh Sleep Quality Index

    Time frame: 5 minutes

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

Association of Physical Activity Level and Sleep Quality with Oxidative Stress and Exercise-related Biomarker Levels in Type 2 Diabetes

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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