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Completed

NCT Number: NCT04261803

FH Detection in Children by Salivary Test

Familial Hypercholesterolemia is a common cause of premature coronary heart disease, it is present in 1 per 500 to 1 per 250 people of the general population. Studies on families of Hypercholesterolemia have shown that children with Hypercholesterolemia have a major increase in risk of coronary heart disease after the age of 20. The difference between Hypercholesterolemia and normal children in their atherogenic profil begin at the age of Nowadays , systematic screening techniques are not well implemented whereas their are clear World health organization guidelines.

International studies show treatment must be initiated early as at the age of eight years old.

In pediatry, Parents can be reluctant to practice blood test on their children. In order to allow more patients to be diagnosed and treated early enough to prevent major complications we need to find an non invasive test.

The main objective is to define the level of detection of cholesterol in saliva with two enzymatic tests. Furthermore we aim to evaluate the performance of salivary detection of cholesterol in children.

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Key information

Conditions

Hyperlipoproteinemia Type II Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon gastro-enterological hepatology and nutrition

Bron, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children under 18 years old, with familial hypercholesterolemia
  • children under 18 years old, intending surgery
  • being able to spit

Exclusion criteria

  • poor dental health
  • for control patients: to have a known cholesterol disease

Treatment and study plan

salivary sample

Biological

spit of saliva in a tube

blood test

Biological

2millilitter blood test

Primary outcomes

  1. salivary cholesterol concentration

    Time frame: Day 1

    the sample will be obtained during one visit non dedicated to this study (following-visit in nutrition for hypercholesterolemia children and before surgery for control children), the swabs of all the 60 patients will be used in two different methods of enzymatic tests.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Familial Hypercholesterolemia Non Invasive Detection in Children by Salivary Test

Acronym: DEPEDIACOL

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2020
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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