Pre DiabetesNCT05052918
The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
A study testing Exercise in people with Pre Diabetes and Exercise, 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 evaluate whether there is a change in carotid intima media thickness with the application of guide-based exercise programs in individuals with prediabetes, and to evaluate whether there is a difference between the group in which exercise programs were applied and those who received only… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pre Diabetes, Exercise, Metformin
- 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
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Sep 2021to 15 Mar 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
- Leading a sedentary life
- Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)
- Have the same weight for 6 months before participating in the study (±2.5 kg)
- Those diagnosed with prediabetes by oral glucose tolerance test and/or HbA1c measurement
Who cannot join
- Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.
- Having cardiovascular disease
- Being diabetic
- Using metformin before participating in the study
- Receiving hormone replacement therapy
- Life expectancy less than 1 year
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- HIV positivity
- Substance use
- Functional dependency
- Cognitive weakness
- Those who have other diseases that will affect the results of the study (respiratory diseases, muscle diseases, etc.)
- Those who use drugs or supplements that will affect the results of the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan Abdülhamid Han Training and Research Hospital
Üsküdar, Istanbul, 34668
Elif Yıldırım Ayaz, M.D., +905325148300, drelifyildirim@hotmail.com
Emine Şeyma Denli Yalvaç, M.D., +905057311317, seymadenli@gmail.com
About this study
The aim of this study is to evaluate whether there is a change in carotid intima media thickness with the application of guide-based exercise programs in individuals with prediabetes, and to evaluate whether there is a difference between the group in which exercise programs were applied and those who received only lifestyle change and metformin.
Read the detailed description
The researchers think that the application of guide-based exercise programs in prediabetes patients will decrease the carotid intima-media thickness.The aim of this study is to evaluate whether there is a change in carotid intima media thickness with the application of guide-based exercise programs in individuals with prediabetes, and to evaluate whether there is a difference between the group in which exercise programs were applied and those who received only lifestyle change and metformin.
- Conditions
- Pre Diabetes, Exercise, Metformin, Atherosclerosis
- Being tested
- Exercise
- Keywords
- Prediabetes, exercise, metformin, atherosclerosis
- Medical subject headings
- Glucose Intolerance, Motor Activity, Atherosclerosis, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | Patients with prediabetes undergoing a 12-week exercise program
(1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks) Receives: Behavioral: Exercise |
| Control | No intervention | Patients with prediabetes with no intervention |
| Metformin | No intervention | Patients with prediabetes using metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid ultrasound
milimeter size of carotid intima media thickness
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start8 Sep 2021
- Primary completion15 Mar 2023 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabetesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elif Yıldırım Ayaz, M.D., Principal investigator, Sultan Abdülhamid Han Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052918
- Sponsor's protocol ID
- EXERCISECIMT
- Status last verified
- Jun 2022
- First submitted
- 7 Sep 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
- ClinicalTrials.gov ID
- NCT05052918
- Acronym / sponsor ID
- EXERCISECIMT
- Conditions
- Pre Diabetes, Exercise, Metformin, Atherosclerosis
- Keywords
- Prediabetes, exercise, metformin, atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 22 Sep 2021 (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 evaluate whether there is a change in carotid intima media thickness with the application of guide-based exercise programs in individuals with prediabetes, and to evaluate whether there is a difference between the group in which exercise programs were applied and those who received only lifestyle change and metformin.
Detailed description
The researchers think that the application of guide-based exercise programs in prediabetes patients will decrease the carotid intima-media thickness.The aim of this study is to evaluate whether there is a change in carotid intima media thickness with the application of guide-based exercise programs in individuals with prediabetes, and to evaluate whether there is a difference between the group in which exercise programs were applied and those who received only lifestyle change and metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Behavioral: ExercisePatients with prediabetes undergoing a 12-week exercise program (1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks) |
| Control | No intervention | –Patients with prediabetes with no intervention |
| Metformin | No intervention | –Patients with prediabetes using metformin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Leading a sedentary life
- Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)
- Have the same weight for 6 months before participating in the study (±2.5 kg)
- Those diagnosed with prediabetes by oral glucose tolerance test and/or HbA1c measurement
Key exclusion criteria (12 listed)
- Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.
- Having cardiovascular disease
- Being diabetic
- Using metformin before participating in the study
- Receiving hormone replacement therapy
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 |
|---|---|---|
| Exercise1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks | Behavioural | Exercise |
Primary outcome
Carotid ultrasound
Time frame: 12 weeks
milimeter size of carotid intima media thickness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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, M.D. principal investigator
Sultan 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 Pre Diabetes and Exercise, 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 22 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Yıldırım Ayaz, M.D. (+905325148300, drelifyildirim@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid ultrasound (time frame: 12 weeks). 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 22 Jun 2022.