Physical Activity Level and Sleep Quality in Type 2 Diabetes

NCT06602778 | Completed

• 1 other identifier: 2024/09.17
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Type 2 Diabetes Mellitus (T2DM); Sleep; Biomarkers / Blood; Physical Activity Level

Outcome Measures

Primary Outcomes (5)

• biomarkers derived from blood sera

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

  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

  10 minutes

• Analysis of exercise-related markers by ELISA method

  10 minutes

• International Physical Activity Questionnaire

  5 minutes

• Pittsburgh Sleep Quality Index

  5 minutes

Study Arms (4)

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

Interventions

Biomarkers / blood OTHER

Analysis of routine biochemical parameters

T2DM-BMI0; T2DM-BMI1; T2DM-BMI2; T2DM-BMI3

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.

T2DM-BMI0; T2DM-BMI1; T2DM-BMI2; T2DM-BMI3

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients applying to the endocrinology department at the medical faculty hospital

You may qualify if:

• Being between 30-65 years old
• Volunteering to participate in the study
• Being literate
• Being diagnosed with Type 2 Diabetes

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Biomarkers; Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biological Factors; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist.Prof.Dr.

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion: October 20, 2024
• Study Completion: February 25, 2025
• Last Updated: March 19, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)