An interventional study of personalized chronoprevention in Clinical Study, sponsored by University Medical Center, Kazakhstan. Not yet recruiting at 1 site in Kazakhstan. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-12-12.
Sponsored by University Medical Center, Kazakhstan · Not applicable, Interventional, and Prevention
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University Medical Center, Kazakhstan is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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
the control group (n=30), where patients with T2D will only be under observation in addition to their traditional prescriptions
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.
Number of Participants with myocardial infarction
occurence of myocardial infarction
Time frame: 24 weeks
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: data will become available to the end of 2025 year, and for 3 years
Access criteria: by requesting
No publications or documents are linked to this record.
Start is estimated for Feb 2023; primary completion for Feb 2025, 24 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 24 months is above that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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University Medical Center, Kazakhstan