Chronoprognosis of Myocardial Infarction in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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. 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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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.

Official Title
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Development of Chronoprognosis of Myocardial Infarction in Patients With Type 2 Diabetes Mellitus and Development of Personalized Chronoprevention

Conditions
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Clinical Study

Intervention / Treatment
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* Behavioral: personalized chronoprevention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged 30-65 years of both sexes severe-to-moderate subcompensated stage of T2D without MI decompensated stage of T2D without MI Exclusion Criteria: compensated stage of T2D without MI patients with T2D and with MI

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: personalized chronoprevention<br>the main group (n=30), where patients with T2D, in addition to their traditional prescriptions, will receive the intervention method of personalized chronoprevention | Behavioral: personalized chronoprevention<br>* 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.<br>|
| No Intervention: traditional prescriptions<br>the control group (n=30), where patients with T2D will only be under observation in addition to their traditional prescriptions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with myocardial infarction | occurence of myocardial infarction | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes mellitus, myocardial infarction, internal personalized biorhythms, external transit rhythms, personalized chronoprevention