NCT06809257

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

January 23, 2025

Last Update Submit

January 29, 2025

Conditions

Keywords

MiR-126ExercisePrediabetesMicroRNA

Outcome Measures

Primary Outcomes (1)

  • Delta CT mir-126

    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 Outcomes (1)

  • BMI

    1 day

Study Arms (2)

Exercise

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

No intervention

Interventions

ExerciseBEHAVIORAL

12 week moderately aerobik exercise

Exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan 2. Abdülhamid Han Training and Research Hospital

Üsküdar, Istanbul, 34660, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prediabetic StateMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elif Yıldırım Ayaz

    Sultan 2. Abdülhamid Han Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

January 23, 2025

First Posted

February 5, 2025

Study Start

May 1, 2021

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

February 5, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations