Clinical StudyNCT05645419
Chronoprognosis of Myocardial Infarction in Patients With Type 2 Diabetes Mellitus
A study testing personalized chronoprevention in people with Clinical Study, run by University Medical Center, Kazakhstan at 1 site in Kazakhstan.
Trial summary
Purpose: To develop a mathematical model for the occurrence of MI in patients with T2D by studying the relationship between the internal personalized biorhythms of the patients and the external transit rhythms of space objects; to develop and implement a personalized method of chrono-prevention of MI in patients with… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Clinical Study
- What is being tested?
- personalized chronoprevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteKazakhstan
- Study dates
- Feb 2023to Jun 2025
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 30-65 years of both sexes
- severe-to-moderate subcompensated stage of T2D without MI
- decompensated stage of T2D without MI
Who cannot join
- compensated stage of T2D without MI
- patients with T2D and with MI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Chronoprognosis of Myocardial Infarction in Patients With Type 2 Diabetes Mellitus and Development of Personalized Chronoprevention
Purpose: To develop a mathematical model for the occurrence of MI in patients with T2D by studying the relationship between the internal personalized biorhythms of the patients and the external transit rhythms of space objects; to develop and implement a personalized method of chrono-prevention of MI in patients with T2D.
Obejectives:
Read more
1.1 To investigate patterns of the influence of external transit rhythms of space objects on the occurrence of MI in patients with T2D: an observational study using clinical databases.
1.2 To investigate patterns of influence of cyclic activity of helio- and geophysical phenomena in the interplanetary medium on the occurrence of MI in patients with T2D.
- Develop a mathematical model for predicting the occurrence of MI in patients with T2D, based on the identification of the relationship patterns between the internal personalized biorhythms of these patients and the external transit rhythms of space objects.
- To investigate the effectiveness of the mathematical model for predicting the occurrence of MI in patients with T2D for the purpose of personalized chrono-prevention: a randomized clinical trial.
Read the detailed description
Participants and study design.
- Study of the influence of external transit rhythms of space objects, as well as the cyclic activity of helio- and geophysical phenomena in the interplanetary medium on the occurrence of MI in patients with T2D combining population based and clinical data. For a retrospective population study, all patients aged 30-65 years with T2D (MI+/-) from the republican database of the Ministry of Health of the Republic of Kazakhstan (MoH) over the past 10 years will be included. For a prospective population trial ≥150 patients aged 30-65 years with T2D (MI+/-) will be included.
- Mathematical and statistical analysis of the collected chrono-geo-biological and clinical data and data on the relationship between the internal personalized biorhythms of the patients and the external transit rhythms of space objects with the definition of "critical periods" as well as the cyclic activity of helio- and geophysical phenomena in the interplanetary medium. Study duration: 12-24 weeks.
- Study of the effectiveness of the developed mathematical model for predicting the occurrence of MI in patients with T2D in a pilot prospective randomized clinical trial (personalized chronoprophylaxis). The study will include at least 60 patients aged 30-65 years of both sexes with moderate T2D: 1) the main group (n≥30), where patients with T2D will additionally receive personalized chronoprevention intervention; 2) the control group (n≥30), where patients with T2D will only be under observation.
- Conditions
- Clinical Study
- Being tested
- personalized chronoprevention
- Keywords
- type 2 diabetes mellitus, myocardial infarction, internal personalized biorhythms, external transit rhythms, personalized chronoprevention
- Medical subject headings
- Diabetes Mellitus, Type 2, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized chronopreventionBehavioural
Chronobiological variables: dynamic and static position of the planets of the solar system, moon, sun, constellations; angles/degrees of celestial objects above/below the horizon; angular interactions between celestial objects; the moment/time of the patients' birth; moment/time of MI occurrence; latitude / longitude of the place of birth of the patients, as well as the occurrence of MI (event); the degree of influence of celestial objects in relation to the constellations, where they were at a particular personal event / points of the patient.
| Study group | Role | What they receive |
|---|---|---|
| personalized chronoprevention | Experimental | the main group (n=30), where patients with T2D, in addition to their traditional prescriptions, will receive the intervention method of personalized chronoprevention Receives: Behavioral: personalized chronoprevention |
| traditional prescriptions | No intervention | the control group (n=30), where patients with T2D will only be under observation in addition to their traditional prescriptions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with myocardial infarction
occurence of myocardial infarction
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study startFeb 2023 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical StudyStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center, Kazakhstan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuat Oshakbayev, University Medical Center, Kazakhstan
- Investigators
- Altay N Nabiyev, Dr., Study director, University Medical Center, Kazakhstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645419
- Sponsor's protocol ID
- AP19675001
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we will make our data available to any investigator/reviewer on their own request, so that the personal privacy of our patients cannot be compromised.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Chronoprognosis of Myocardial Infarction in Patients With Type 2 Diabetes Mellitus and Development of Personalized Chronoprevention
- ClinicalTrials.gov ID
- NCT05645419
- Acronym / sponsor ID
- AP19675001
- Conditions
- Clinical Study
- Keywords
- type 2 diabetes mellitus, myocardial infarction, internal personalized biorhythms, external transit rhythms, personalized chronoprevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Medical Center, KazakhstanUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 9 Dec 2022 (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.
Purpose: To develop a mathematical model for the occurrence of MI in patients with T2D by studying the relationship between the internal personalized biorhythms of the patients and the external transit rhythms of space objects; to develop and implement a personalized method of chrono-prevention of MI in patients with T2D.
Obejectives:
1.1 To investigate patterns of the influence of external transit rhythms of space objects on the occurrence of MI in patients with T2D: an observational study using clinical databases.
1.2 To investigate patterns of influence of cyclic activity of helio- and geophysical phenomena in the interplanetary medium on the occurrence of MI in patients with T2D.
- Develop a mathematical model for predicting the occurrence of MI in patients with T2D, based on the identification of the relationship patterns between the internal personalized biorhythms of these patients and the external transit rhythms of space objects.
- To investigate the effectiveness of the mathematical model for predicting the occurrence of MI in patients with T2D for the purpose of personalized chrono-prevention: a randomized clinical trial.
Detailed description
Participants and study design.
- Study of the influence of external transit rhythms of space objects, as well as the cyclic activity of helio- and geophysical phenomena in the interplanetary medium on the occurrence of MI in patients with T2D combining population based and clinical data. For a retrospective population study, all patients aged 30-65 years with T2D (MI+/-) from the republican database of the Ministry of Health of the Republic of Kazakhstan (MoH) over the past 10 years will be included. For a prospective population trial ≥150 patients aged 30-65 years with T2D (MI+/-) will be included.
- Mathematical and statistical analysis of the collected chrono-geo-biological and clinical data and data on the relationship between the internal personalized biorhythms of the patients and the external transit rhythms of space objects with the definition of "critical periods" as well as the cyclic activity of helio- and geophysical phenomena in the interplanetary medium. Study duration: 12-24 weeks.
- Study of the effectiveness of the developed mathematical model for predicting the occurrence of MI in patients with T2D in a pilot prospective randomized clinical trial (personalized chronoprophylaxis). The study will include at least 60 patients aged 30-65 years of both sexes with moderate T2D: 1) the main group (n≥30), where patients with T2D will additionally receive personalized chronoprevention intervention; 2) the control group (n≥30), where patients with T2D will only be under observation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| personalized chronoprevention | Experimental | Behavioral: personalized chronopreventionthe main group (n=30), where patients with T2D, in addition to their traditional prescriptions, will receive the intervention method of personalized chronoprevention |
| traditional prescriptions | No intervention | –the control group (n=30), where patients with T2D will only be under observation in addition to their traditional prescriptions |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged 30-65 years of both sexes
- severe-to-moderate subcompensated stage of T2D without MI
- decompensated stage of T2D without MI
Key exclusion criteria (2 listed)
- compensated stage of T2D without MI
- patients with T2D and with MI
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 |
|---|---|---|
| personalized chronopreventionChronobiological variables: dynamic and static position of the planets of the solar system, moon, sun, constellations; angles/degrees of celestial objects above/below the horizon; angular interactions between celestial objects; the moment/time of the patients' birth; moment/time of MI occurrence; latitude / longitude of the place of birth of the patients, as well as the occurrence of MI (event); the degree of influence of celestial objects in relation to the constellations, where they were at a particular personal event / points of the patient. | Behavioural | personalized chronoprevention |
Primary outcome
Number of Participants with myocardial infarction
Time frame: 24 weeks
occurence of myocardial infarction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: Yes. we will make our data available to any investigator/reviewer on their own request, so that the personal privacy of our patients cannot be compromised.
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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.
Altay N Nabiyev, Dr. study director
University Medical Center, Kazakhstan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized chronoprevention in people with Clinical Study, run by University Medical Center, Kazakhstan at 1 site in Kazakhstan.
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 3 inclusion and 2 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 12 Dec 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 Kazakhstan. 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 Kuat P Oshakbayev, professor (+77013999394, okp.kuat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with myocardial infarction (time frame: 24 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 12 Dec 2022.