FH Detection in Children by Salivary Test

Completed

• Conditions: Hyperlipoproteinemia Type II
• Interventions: Biological: salivary sample; Biological: blood test

• Registration Number: NCT04261803
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-10
• Study Start: 2020-02-18
• Primary Completion: 2020-08-26
• Study Completion: 2020-08-26
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Familial Hypercholesterolemia children	blood test	-
Control children	salivary sample	-
Control children	blood test	-
Familial Hypercholesterolemia children	salivary sample	-

Primary Outcome Measures

Name	Time	Method
salivary cholesterol concentration	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.

Trial Locations

Locations (1)

Hospices Civils de Lyon gastro-enterological hepatology and nutrition; 🇫🇷 Bron, France