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Chronoprognosis of Myocardial Infarction in Patients With Type 2 Diabetes Mellitus

Primary Purpose

Clinical Study

Status
Not yet recruiting
Phase
Not Applicable
Locations
Kazakhstan
Study Type
Interventional
Intervention
personalized chronoprevention
Sponsored by
University Medical Center, Kazakhstan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clinical Study focused on measuring type 2 diabetes mellitus, myocardial infarction, internal personalized biorhythms, external transit rhythms, personalized chronoprevention

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kuat Pernekulovich Oshakbayev

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

personalized chronoprevention

traditional prescriptions

Arm Description

the main group (n=30), where patients with T2D, in addition to their traditional prescriptions, will receive the intervention method of personalized chronoprevention

the control group (n=30), where patients with T2D will only be under observation in addition to their traditional prescriptions

Outcomes

Primary Outcome Measures

Number of Participants with myocardial infarction
occurence of myocardial infarction

Secondary Outcome Measures

Full Information

First Posted
December 1, 2022
Last Updated
December 8, 2022
Sponsor
University Medical Center, Kazakhstan
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1. Study Identification

Unique Protocol Identification Number
NCT05645419
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center, Kazakhstan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Study
Keywords
type 2 diabetes mellitus, myocardial infarction, internal personalized biorhythms, external transit rhythms, personalized chronoprevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
personalized chronoprevention
Arm Type
Experimental
Arm Description
the main group (n=30), where patients with T2D, in addition to their traditional prescriptions, will receive the intervention method of personalized chronoprevention
Arm Title
traditional prescriptions
Arm Type
No Intervention
Arm Description
the control group (n=30), where patients with T2D will only be under observation in addition to their traditional prescriptions
Intervention Type
Behavioral
Intervention Name(s)
personalized chronoprevention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants with myocardial infarction
Description
occurence of myocardial infarction
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuat P Oshakbayev, professor
Phone
+77013999394
Email
okp.kuat@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Altay N Nabiyev, Dr.
Organizational Affiliation
University Medical Center, Kazakhstan
Official's Role
Study Director
Facility Information:
Facility Name
Kuat Pernekulovich Oshakbayev
City
Astana
ZIP/Postal Code
010000
Country
Kazakhstan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
data will become available to the end of 2025 year, and for 3 years
IPD Sharing Access Criteria
by requesting

Learn more about this trial

Chronoprognosis of Myocardial Infarction in Patients With Type 2 Diabetes Mellitus

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