Chronoprognosis of Myocardial Infarction in Patients With Type 2 Diabetes Mellitus

NCT05645419 | Unknown DMC

• 1 other identifier: AP19675001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Study

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with myocardial infarction

  occurence of myocardial infarction

  24 weeks

Study Arms (2)

personalized chronoprevention

EXPERIMENTAL

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

traditional prescriptions

NO INTERVENTION

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

Interventions

personalized chronoprevention 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.

personalized chronoprevention

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 30-65 years of both sexes
• severe-to-moderate subcompensated stage of T2D without MI
• decompensated stage of T2D without MI

You may not qualify if:

• compensated stage of T2D without MI
• patients with T2D and with MI

Sponsors & Collaborators

• University Medical Center, Kazakhstan: lead

Study Sites (1)

Kuat Pernekulovich Oshakbayev

Astana, 010000, Kazakhstan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Myocardial Infarction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Altay N Nabiyev, Dr.

  University Medical Center, Kazakhstan

  STUDY DIRECTOR

Central Study Contacts

Kuat P Oshakbayev, professor

CONTACT

+77013999394; okp.kuat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: a principal investigator

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data will become available to the end of 2025 year, and for 3 years
• Access Criteria: by requesting

Locations

KA (1)