Hypertension in High School Students

NCT06049641 | Completed DMC

• 1 other identifier: HYGEF STUDY
• Study Type: observational
• Target: 2,638
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension and obesity in the young population are major risk factors for renal and cardiovascular events, which could arise in adulthood. A candidate-gene approach will be applied in a cohort observational study, in which investigators will collect data from high school adolescent students. Participants underwent anthropometric and blood pressure measurements, as well as saliva and urine sample collection for genomic DNA extraction and renal function evaluation, respectively. Candidate genes previously implicated in salt-sensitive hypertension in adults will be tested to verify impact on blood pressure (BP) also among adolescents. Since inflammatory mechanisms may be involved in pathophysiology of hypertension and in endothelial dysfunction and atherosclerosis through reactive oxygen species, the baseline urinary excretion of inflammatory and oxidative stress markers in a subgroup of adolescents stratified according to ADD1 (alpha adducin) rs4961 genotypes will be assessed.

Conditions

Hypertension in Adolescence; Adolescent Overweight

Keywords

hypertension; adolescence; obesity; genetic

Outcome Measures

Primary Outcomes (1)

• The aim of the study was to establish a link of specific polymorphisms of Adducins and EO-related genes with selected phenotypes (hypertension, Na+ and K+ intake).

  2 years

Study Arms (2)

13 to 15 Year-Old

* Normotensive (Normal BP): SBP and/or DBP values below the 90th percentile for teens of the same age and sex. * Prehypertensive (High-normal BP): SBP and/or DBP values at or above the 90th percentile and/or below the 95th percentile for for teens of the same age and sex. * Hypertensive: SBP and/or DBP values at or above the 95th percentile for teens of the same age and sex.

16 to 19 Year-Old

* Normotensive (Normal BP): SBP \<130 mmHg and/or DBP \<85 mm Hg. * Prehypertensive (High-normal BP): SBP 130 to 139 mmHg and/or DBP 85 to 89 mm Hg. * Hypertensive: SBP ≥140 mm Hg and/or DBP ≥90 mmHg.

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The final sample included 2638 white adolescents, 56% were females, 30% were from Milano (North Italy), 44% from Livorno (central Italy), and 26% from Grottaglie (South Italy).

You may qualify if:

• Age between 13 and 19 years old
• Caucasian

You may not qualify if:

• Age more than 19 years old
• Not Caucasian

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Related Publications (48)

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Biospecimen

Retention: SAMPLES WITH DNA

* Saliva * concentrated DNA in biobank

MeSH Terms

Conditions

Pediatric Obesity; Hypertension; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Nephrology

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 22, 2023
• Study Start: October 31, 2014
• Primary Completion: May 31, 2017
• Study Completion: October 30, 2018
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

IT (1)