Early Vascular Ageing in the YOUth

Obesity Clinical Trial

— EVA4YOU  

Official title:

Early Vascular Ageing in the YOUth - An Observational Study Into the Predictors of Atherosclerotic Changes in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04598685
• Other study ID #: EVA4YOU
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: VASCage GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a single-center observational study on adolescents to determine predictors of the early steps of the formation of atherosclerosis and to quantify their influence on Intima-Media-Thickness of the carotid artery and the aorta and on the Pulse-Wave Velocity.

A long-term follow-up by means of record linkage is furthermore planned to evaluate the effect of early atherosclerosis and the cardiovascular risk profile on future morbidity with a special focus cardio- and cerebrovascular events.

Description:

EVA4YOU is a cross-sectional study enrolling 3000 students and apprentices aged between 14 and 19 years. Examinations are conducted at schools and companies throughout Tyrol, Austria and include laboratory measurements; standardized medical interviews; anthropometry; liver elastography; ultrasonography of the carotid artery and the aorta, and blood pressure, bioelectrical impedance; visceral abdominal fat-tissue-thickness measurement, pulse-wave velocity measurements.

The study hypothesis is that the cardiovascular risk factors measured already influence the formation of atherosclerosis (measured as carotid and aortic Intima-Media Thickness and Pulse-Wave-Velocity) in adolescents.

A long-term follow-up by means of record linkage is furthermore planned to evaluate the effect of early atherosclerosis and the cardiovascular risk profile on future morbidity with a special focus cardio- and cerebrovascular events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1517
• Est. completion date: March 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

Inclusion Criteria:

• Adolescents at the age of 14 to 19 years

• Signed informed consent of subjects (and legal guardian if subject < 18 years of age)

Exclusion Criteria:

• Persons, who are suspended upon a court order or upon other legal processes or are accommodated according to the Hospitalization Act, or for whom a custodian is appointed (or appointment is initiated).

• Persons with impaired power of judgment

• Persons who are currently engaged in military or community service

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Cardiovascular Pathology
• Cardiovascular Risk Factor
• Fatty Liver
• Headache
• Hypertension
• Life Style
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Obesity
• Overweight
• Sleep
• Sleep Disorder
• Sleep Wake Disorders
• Vascular Diseases
• Vascular Stiffness

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck	Tyrol

Sponsors (3)

Lead Sponsor	Collaborator
VASCage GmbH	Medical University Innsbruck, Tirol Kiniken GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The effect of primary headache disorders on Intima-Media Thickness [µm]	Primary Headache Disorders are assessed by means of structured medical questionnaires in a physician-guided interview and classified according to the ICHD-3 Classification System. Differences in terms of vessel wall thickness [µm], measured ultrasonographically, are compared across the different primary headache diagnoses.	Day 1
Other	The effect of primary headache disorders on Pulse-Wave Velocity [m/s]	Primary Headache Disorders are assessed by means of structured medical questionnaires in a physician-guided interview and classified according to the ICHD-3 Classification System. Differences in terms of pulse-wave velocity [m/s], measured with use of an oscillometric pulse-wave measurement device, are compared across the different primary headache diagnoses.	Day 1
Other	The effect of the gut microbiome on the cardiovascular risk profile.	Structure and composition of the Microbiom using 16S metagenomics and shotgun metagenomics and are evaluate for their interrelationship with cardiovascular risk parameters (such as hypertension, smoking, dyslipidemia, impaired glucose tolerance, overweight/obesity, sedentary lifestyle, unhealthy dietary habits, ...).; Where appropriate additional functional insight will be obtained by metabolomics (gas chromatography and MR chromatography).	Day 1
Other	The effect of the gut microbiome on Intima-Media Thickness [µm]	Structure and composition of the Microbiom using 16S metagenomics and shotgun metagenomics and are assessed using stool samples and are evaluate for their influence on intima-media thickness, measured via ultrasonography. Where appropriate additional functional insight will be obtained by metabolomics (gas chromatography and MR chromatography).	Day 1
Other	The effect of prenatal and infant development (early life risk factors) on Intima-Media Thickness [µm].	Prenatal and infant development is assessed using records from mother-child-booklets and a questionnaire for the mother and the influence on intima-media thickness, measured using ultrasonography, is evaluated.	Day 1
Other	The effect of prenatal and infant development (early life risk factors) on the cardiovascular risk profile.	Prenatal and infant development is assessed using records from mother-child-booklets and a questionnaire for the mother and the influence on the cardiovascular risk profile (i.e. existence of cardiovascular risk factors such as hypertension, smoking, dyslipidemia, impaired glucose tolerance, overweight/obesity, sedentary lifestyle, unhealthy dietary habits, ...) is evaluated.	Day 1
Other	Prevalence of headache disorders (especially primary headache disorders) in adolescents	Headache Disorders are assessed by means of structured medical questionnaires (including duration, frequency, intensity, headache characteristics and concomitant symptoms) in a physician-guided interview and classified according to the ICHD-3 Classification System.	Day 1
Other	Risk factors for primary headache disorders in adolescents	Headache Disorders are assessed by means of structured medical questionnaires (including duration, frequency, intensity, headache characteristics and concomitant symptoms) in a physician-guided interview and classified according to the ICHD-3 Classification System.; Risk factors to be assessed for their association with primary headache disorders include: Alcohol, caffeine and nicotine consumption, physical activity, obesity, dysfunctional familial situation, mental comorbidities are assessed in structured physician-guided interviews and questionnaires.	Day 1
Other	Risk factors for the chronification of primary headache-disorders	Headache Disorders are assessed by means of structured medical questionnaires (including duration, frequency, intensity, headache characteristics and concomitant symptoms) in a physician-guided interview and classified according to the ICHD-3 Classification System.; Risk factors to be assessed for their effect on chronification of primary headache disorders include: Alcohol, caffeine and nicotine consumption, physical activity, obesity, dysfunctional familial situation, mental comorbidities are assessed in structured physician-guided interviews and questionnaires.	Day 1
Primary	Determinants of Intima-Media Thickness (carotid and aortic)	Predictors to be examined include: Blood Pressure, BMI/body composition, Smoking, Physical Activity, Family History, Lipid and Glucose Metabolism, NAFLD, Diet, Sex, Age used as predictors in multiple regression analysis	Day 1
Primary	Determinants of the Pulse-Wave Velocity [m/s]	Predictors to be examined include: Blood Pressure, BMI/body composition, Smoking, Physical Activity, Family History, Lipid and Glucose Metabolism, NAFLD, Diet, Sex, Age used as predictors in multiple regression analysis; The pulse-wave velocity [m/s] is measured by using the Vicorder, an oscillometric pulse-wave measurement device.	Day 1
Secondary	Predictors of later cardio- and cerebrovascular disease (events and mortality) by record linkage	Occurence of major adverse cardiovascular events (yes/no, time to event), assessed by means of automated detection of these events by record linkage	every 2-5 years, on average for the duration of 50 years
Secondary	Prevalence of traditional cardiovascular risk and lifestyle factors and descripition of high-risk populations		Day 1
Secondary	Time trends in risk profiles by comparison to data from the Early Vascular Ageing (EVA) study, NCT03929692		8 years