Effect of Exercise on MiR-126 in Individuals With Prediabetes (EMiR-126-PD)

January 29, 2025 updated by: Elif Yıldırım Ayaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Effect of Exercise on MiR-126 in Individuals With Prediabetes: A Randomized Controlled Trial

This study aims to investigate the effect of a structured exercise program on microRNA-126 (miR-126) expression in individuals with prediabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to investigate the effect of a structured exercise program on microRNA-126 (miR-126) expression in individuals with prediabetes. The hypothesis of our study is that regular aerobic exercise will increase miR-126 expression. Determining the effect of exercise on miR-126 in individuals with prediabetes will contribute to the elucidation of the pathways through which exercise is effective in prediabetes via epigenetic mechanisms.

Study Type

Interventional

Enrollment (Actual)

64

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

  • Turkey
    • İstanbul
      • Üsküdar, İstanbul, Turkey, 34660
        • Sultan 2. Abdulhamid Han Training and Research Hospital

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals who were newly diagnosed with prediabetes according to the Oral Glucose Tolerance Test (OGTT) and/or HbA1C criteria
  • between the ages of 18-60
  • were physically inactive (Level 1 according to the International Physical Activity Questionnaire)
  • were motivated to exercise
  • Individuals who had no obstacle to exercise as a result of the evaluation made by a cardiologist (ECG, exercise ECG test, etc.)
  • and who did not show a change in body weight of more than ±2.5 kg in the last six months were included in the study.

Exclusion Criteria:

  • presence of serious medical conditions (e.g. advanced cancer, major neurological or endocrine disorders, respiratory failure)
  • current cardiovascular disease, BMI <19 kg/m²
  • history of metformin use within the last 6 months
  • receiving hormone replacement therapy
  • life expectancy less than one year
  • HIV positivity
  • substance use
  • or orthopedic and cognitive disorders that may prevent exercise

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Active Comparator: Exercise
Individuals in the intervention group were included in a planned aerobic exercise program for 12 weeks.This program was carried out under the supervision of specialist doctors, with the help of sports trainers and physiotherapists, and participants were given 60 minutes of moderate-intensity (50-70% of their maximum heart rate) aerobic exercise three days a week.
Behavioral: Exercise
12 week moderately aerobik exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delta CT mir-126
Time Frame: 1 week

Ct (cycle threshold) values for miR-126 and miR-16-5p were used for analysis. ΔCt and ΔΔCt values were calculated as follows, and expression levels were analyzed using the 2-ΔΔCt method:

∆Ct = Ct (gene of interest) - Ct (housekeeping gene) ΔΔCt = ∆Ct (treated sample) - ∆Ct (untreated sample) Higher ΔCt values indicate lower expression levels.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 1 day
The BMI is calculated by dividing an adult's weight in kilograms by their height in metres squared.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

  • Principal Investigator: Elif Yıldırım Ayaz, Sultan 2. Abdulhamid Han Training and Research Hospital

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)

May 1, 2021

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMiR-126-PD
  • Saglik Bilimleri University (Saglik Bilimleri University)

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

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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