Chronoprognosis of Myocardial Infarction in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT05645419
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-02-28
2025-06-30
Brief Summary
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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.
2\. 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.
3\. 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
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1. 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.
2. 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.
3. 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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personalized chronoprevention
the main group (n=30), where patients with T2D, in addition to their traditional prescriptions, will receive the intervention method of personalized chronoprevention
personalized chronoprevention
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.
traditional prescriptions
the control group (n=30), where patients with T2D will only be under observation in addition to their traditional prescriptions
No interventions assigned to this group
Interventions
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personalized chronoprevention
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.
Eligibility Criteria
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Inclusion Criteria
* severe-to-moderate subcompensated stage of T2D without MI
* decompensated stage of T2D without MI
Exclusion Criteria
* patients with T2D and with MI
35 Years
65 Years
ALL
No
Sponsors
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University Medical Center, Kazakhstan
OTHER
Responsible Party
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Kuat Oshakbayev
a principal investigator
Principal Investigators
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Altay N Nabiyev, Dr.
Role: STUDY_DIRECTOR
University Medical Center, Kazakhstan
Locations
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Kuat Pernekulovich Oshakbayev
Astana, , Kazakhstan
Countries
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Central Contacts
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Other Identifiers
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AP19675001
Identifier Type: -
Identifier Source: org_study_id