Chronoprognosis of Myocardial Infarction in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT05645419

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clinical Study

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

type 2 diabetes mellitus myocardial infarction internal personalized biorhythms external transit rhythms personalized chronoprevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

personalized chronoprevention

Intervention Type BEHAVIORAL

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Medical Center, Kazakhstan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kuat Oshakbayev

a principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Altay N Nabiyev, Dr.

Role: STUDY_DIRECTOR

University Medical Center, Kazakhstan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kuat Pernekulovich Oshakbayev

Astana, , Kazakhstan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Kazakhstan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kuat P Oshakbayev, professor

Role: CONTACT

Phone: +77013999394

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AP19675001

Identifier Type: -

Identifier Source: org_study_id