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Completed

NCT Number: NCT06809257

Effect of Exercise on MiR-126 in Individuals With Prediabetes

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

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Key information

Conditions

PreDiabetes Behavior Diabetes Mellitus Endocrine System Diseases Exercise Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Prediabetic State microRNA

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan 2. Abdülhamid Han Training and Research Hospital

Üsküdar, Istanbul, 34660, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Exercise

Behavioral

12 week moderately aerobik exercise

Primary outcomes

  1. 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.

Secondary outcomes

  1. BMI

    Time frame: 1 day

    The BMI is calculated by dividing an adult's weight in kilograms by their height in metres squared.

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

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

Acronym: EMiR-126-PD

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2025
Registry last updated
Feb 5, 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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