Risk Factors at Chronic Non-communicable Diseases in People of Working Age

NCT06812767 | Enrolling By Invitation

• 1 other identifier: 05-05/24
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: to study the clinical and demographic characteristics of working age persons, to highlight the main factors of non-communicable diseases (NCDs), to identify NCDs with physical examination, laboratory tests, electrocardiography and ultrasound imaging, to develop a corporate prevention program for the company to reduce the risk of complications of NCDs. Research stages:

1. 1.Questionnaire to identify socio-demographic, behavioral, hereditary, psycho-emotional risk factors of NCDs
2. 2.Laboratory tests (analysis of glucose and cholesterol in the capillary blood, detection of microalbuminuria), diagnostic tests (electrocardiography, and carotid artery ultrasound)
3. 3.Evaluation of the results of questionnaires and surveys. Recommendations for lifestyle modification and follow-up in a local healthcare department

Conditions

Chronic Non-communicable Disease

Keywords

arterial hypertension; coronary heart disease; cerebrovascular disease; malignant tumors; chronic obstructive pulmonary disease; asthma; diabetes mellitus; environment; smoking; alcohol consumption; unbalanced diet; hypodynamia; obesity; overweight; dyslipidemia; hyperglycemia; microalbuminuria

Outcome Measures

Primary Outcomes (2)

• prevalence of NCDs risk factors

  risk factors of NCDs based on survey results and diagnostic tests

  on enrollment

• prevalence of NCDs

  diagnosed NCDs based on survey results, and diagnostic tests

  on enrollment

Secondary Outcomes (1)

• Hospitalization

  on enrollment

Study Arms (1)

Persons without NCDs

Persons without known NCDs and not using any medication on a permanent basis

Diagnostic Test: electrocardiography; Diagnostic Test: analysis for glucose and cholesterol in the capillary blood; Diagnostic Test: detection of microalbumuria; Diagnostic Test: heart ultrasound examination; Diagnostic Test: carotid artery ultrasound examination

Interventions

electrocardiography DIAGNOSTIC_TEST

12 standard leads

Persons without NCDs

analysis for glucose and cholesterol in the capillary blood DIAGNOSTIC_TEST

express test

Persons without NCDs

detection of microalbumuria DIAGNOSTIC_TEST

express test

Persons without NCDs

heart ultrasound examination DIAGNOSTIC_TEST

Ultrasound examination with Lumify Handheld S4-1 Phased Array Ultrasound (Philips)

Persons without NCDs

carotid artery ultrasound examination DIAGNOSTIC_TEST

Ultrasound examination with Lumify Handheld L12-4 Linear Array Ultrasound (Philips)

Persons without NCDs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study is planned to include all working citizens who meet the inclusion criteria and have come for preventive examination. In total, at least 2,000 people are planned to be included in the study. All participants will be given informed consent to participate in the clinical trial

You may qualify if:

• employees of the company
• persons without NCDs diagnosis and not receiving permanent medication
• residents of the region of the Russian Federation where a factory with permanent or temporary registration is located

You may not qualify if:

• refusal to sign informed consent
• any NCDs requiring constant medication
• active cancer
• pulmonary embolism
• valve defects of the heart (except secondary mitral regurgitation)

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead

Study Sites (1)

National Medical Research Center for Therapy and Preventive Medicine

Moscow, Russia

Location

Biospecimen

Retention: NONE RETAINED

blood and urine samples

MeSH Terms

Conditions

Noncommunicable Diseases; Hypertension; Coronary Disease; Cerebrovascular Disorders; Neoplasms; Pulmonary Disease, Chronic Obstructive; Asthma; Diabetes Mellitus; Smoking; Alcohol Drinking; Hypokinesia; Obesity; Overweight; Dyslipidemias; Hyperglycemia

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Drinking Behavior; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Overnutrition; Nutrition Disorders; Body Weight; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Olga Dzhioeva, MD, PhD

  National Medical Research Center for Therapy and Preventive Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 6, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

RU (1)