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Clinical Trials/NCT06809257
NCT06809257CompletedNot Applicable

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

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey2 sites in 1 country64 target enrollmentStarted: May 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
64
Locations
2
Primary Endpoint
Delta CT mir-126

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • BMI(1 day)

Investigators

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elif Yıldırım Ayaz

Assoc. Prof. Dr.

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Study Sites (2)

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