PrediabetesEMiR-126-PDNCT06809257
Effect of Exercise on MiR-126 in Individuals With Prediabetes
A study testing Exercise in people with Prediabetes and microRNA, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effect of a structured exercise program on microRNA-126 (miR-126) expression in individuals with prediabetes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prediabetes, microRNA, Exercise
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan 2. Abdülhamid Han Training and Research Hospital
Üsküdar, Istanbul, 34660
About this study
Official title: 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.
Read the 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.
- Conditions
- Prediabetes, microRNA, Exercise
- Being tested
- Exercise
- Keywords
- MiR-126, Exercise, Prediabetes, MicroRNA
- Medical subject headings
- Prediabetic State, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
12 week moderately aerobik exercise
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (1)
BMI
The BMI is calculated by dividing an adult's weight in kilograms by their height in metres squared.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 May 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Yıldırım Ayaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Elif Yıldırım Ayaz, Principal investigator, Sultan 2. Abdülhamid Han Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809257
- Sponsor's protocol ID
- EMiR-126-PD
- Other IDs
- Saglik Bilimleri University
- Acronym
- EMiR-126-PD
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on MiR-126 in Individuals With Prediabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06809257
- Acronym / sponsor ID
- EMiR-126-PD / EMiR-126-PD
- Conditions
- Prediabetes, microRNA, Exercise
- Keywords
- MiR-126, Exercise, Prediabetes, MicroRNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Behavioral: ExerciseIndividuals 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. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise12 week moderately aerobik exercise | Behavioural | Exercise |
Primary outcome
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 secondary outcome
BMI
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Yıldırım Ayaz principal investigator
Sultan 2. Abdülhamid Han Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Prediabetes and microRNA, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta CT mir-126 (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.