MethylglyoxalNCT06603480
Effects of Exercise and Metformin on Methylglyoxal Levels in Prediabetic Individuals
A study testing Exercise and Metformin in people with Methylglyoxal and PreDiabetes, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Methylglyoxal, PreDiabetes, Exercise
- What is being tested?
- Exercise and Metformin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2021to 7 Dec 2022
- 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
- Patients who were newly diagnosed with prediabetes by Oral Glucose Tolerance Test (OGTT) and/or HbA1C,
- who were assessed as physically inactive (Level 1) according to the International Physical Activity Questionnaire
- who had sufficient motivation to participate in the exercise program (assessed by one-on-one interviews conducted by the researchers),
- who were deemed suitable to participate in the exercise program after a cardiac examination by a cardiologist (with resting electrocardiogram and questioning of cardiac symptoms, and advanced tests such as exercise electrocardiogram test when necessary),
- who had the same weight (±2.5 kg) for 6 months before participating in the study.
Who cannot join
- having a serious medical condition that would prevent the person from participating in the exercise study (e.g. advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.),
- having used metformin for 6 months before the study, having cardiovascular disease,
- heart failure, cancer, having a BMI \<19 kg/m2, receiving hormone replacement therapy,
- having a life expectancy of less than 1 year, being HIV positive, substance use,
- functional dependence, having an orthopedic disease that prevents physical activity,
- having cognitive impairment and other diseases that would affect the study results (respiratory diseases, muscle diseases, non-alcoholic fatty liver disease, etc.),
- using medications or supplements that would affect the study results.
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
The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals.
Read the detailed description
There is no comparative study in the literature evaluating the effects of exercise and metformin on MGO in prediabetic patients. The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals.
- Conditions
- Methylglyoxal, PreDiabetes, Exercise, Metformin
- Being tested
- Exercise, Metformin
- Keywords
- Physical activity, PreDiabetes, Metformin, Methylglyoxal
- 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
Aerobic exercise (moderate intensity) at 50-70% of maximum heart rate for 60 minutes, 3 days a week for 12 weeks
MetforminOther
Patients who started Metformin 2*1
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Active comparator | 12 week aerobic exercise Receives: Behavioral: Exercise |
| Metformin | Experimental | Metformin 2*1 given Receives: Other: Metformin |
| Control | No intervention | Only routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
MGO
Methylgloxal level
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Apr 2021
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MethylglyoxalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603480
- Sponsor's protocol ID
- MEGS
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise and Metformin on Methylglyoxal Levels in Prediabetic Individuals
- ClinicalTrials.gov ID
- NCT06603480
- Acronym / sponsor ID
- MEGS
- Conditions
- Methylglyoxal, PreDiabetes, Exercise, Metformin
- Keywords
- Physical activity, PreDiabetes, Metformin, Methylglyoxal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 19 Sep 2024 (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.
The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals.
Detailed description
There is no comparative study in the literature evaluating the effects of exercise and metformin on MGO in prediabetic patients. The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Active comparator | Behavioral: Exercise12 week aerobic exercise |
| Metformin | Experimental | Other: MetforminMetformin 2*1 given |
| Control | No intervention | –Only routine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who were newly diagnosed with prediabetes by Oral Glucose Tolerance Test (OGTT) and/or HbA1C,
- who were assessed as physically inactive (Level 1) according to the International Physical Activity Questionnaire
- who had sufficient motivation to participate in the exercise program (assessed by one-on-one interviews conducted by the researchers),
- who were deemed suitable to participate in the exercise program after a cardiac examination by a cardiologist (with resting electrocardiogram and questioning of cardiac symptoms, and advanced tests such as exercise electrocardiogram test when necessary),
- who had the same weight (±2.5 kg) for 6 months before participating in the study.
Key exclusion criteria (7 listed)
- having a serious medical condition that would prevent the person from participating in the exercise study (e.g. advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.),
- having used metformin for 6 months before the study, having cardiovascular disease,
- heart failure, cancer, having a BMI \<19 kg/m2, receiving hormone replacement therapy,
- having a life expectancy of less than 1 year, being HIV positive, substance use,
- functional dependence, having an orthopedic disease that prevents physical activity,
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 |
|---|---|---|
| ExerciseAerobic exercise (moderate intensity) at 50-70% of maximum heart rate for 60 minutes, 3 days a week for 12 weeks | Behavioural | Aerobic Exercise |
| MetforminPatients who started Metformin 2*1 | Other | Metformin |
Primary outcome
MGO
Time frame: 1 week
Methylgloxal level
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 19 Sep 2024.
Related trials for Methylglyoxal
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Metformin in people with Methylglyoxal and PreDiabetes, 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 5 inclusion and 7 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 19 Sep 2024. 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?
MGO (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 19 Sep 2024.