Clinical trial NCT05645419: Chronoprognosis of Myocardial Infarction in Patients With Type 2 Diabetes Mellitus
Official title: Development of Chronoprognosis of Myocardial Infarction in Patients With Type 2 Diabetes Mellitus and Development of Personalized Chronoprevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clinical Study
Keywords: type 2 diabetes mellitus
myocardial infarction
internal personalized biorhythms
external transit rhythms
personalized chronoprevention
Lead sponsor: University Medical Center, Kazakhstan
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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: Participants and study design.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with myocardial infarction
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: Kuat Pernekulovich Oshakbayev
Study officials:
affiliation: University Medical Center, Kazakhstan
name: Altay N Nabiyev, Dr.
role: STUDY_DIRECTOR
References: