NCT03206957

Correlation Between Optic Nerve Vessel Anomalies, Serum Angiogenic Factors and Renal Anomalies in Down Syndrome Children

Interventional Controlled Cross-sectional Study Assessing the Correlation Between Optic Nerve Vessels Anomalies, Serum Angiogenic Factors and Renal Anomalies in Children With Down Syndrome.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Queen Fabiola Children's University Hospital · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Accepted

Summary

In approximately half of individuals with Down syndrome, an higher than normal number of vessels cross the optic disc margin. Investigator hypothesize that early retinal vessel branching occurs due to inhibition of angiogenesis by triplet overexpression of endostatin, an angiogenesis inhibitor encoded on chromosome 21. Since angiogenesis is critical in the development of eyes and other organs angiogenesis depended (specially kidney, brain, and recently described lungs and heart), early branching of retinal vessels at the level of the optic disc would also likely result in abnormal renal and other organs development in these individuals. Investigator wish to determine whether observation of optic disc vessels may serve as an indicator of elevated endostatin levels and other angiogenesis-dependent organs anomalies.

Detailed description

Investigator will measure the serum levels of endostatin as well as others angiogenetic factors in Down syndrome children versus control group 1 constituted by the patient mothers. Investigator will also perform renal and low urinary tract Doppler ultrasound with measurement of renal dimension in order to determine if the kidneys of patients with high level of serum of endostatin are smaller than those of patients with normal level of endostatin. Data observed in Down syndrome children will be compared to control group 2age constituted by sex and age matched healthy children Urine microalbuminuria and urine microalbuminuria/creatinuria from the first urine in the morning will be evaluated.

Conditions

• Down Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Funduscopic examination and retinal photography	A standardized funduscopic examination and retinal photography will be performed by an ophthalmologist focusing on optic nerve.
DIAGNOSTIC_TEST	Serum levels of endostatin and angiogenesis factors	Serum levels of endostatin, angiopoietin and vaso endothelial growth factor will be analyzed
DIAGNOSTIC_TEST	Renal and low urinary tract Doppler ultrasound	Measurements of each kidney will include maximum renal bipolar length in a sagittal plane, renal width and thickness in an axial plane perpendicular to each other at the level of renal hilum and cortical thickness. Intensity of corticomedullary differentiation will estimated. Doppler ultrasound examination will assess renal arterial resistivity indexes
DIAGNOSTIC_TEST	Urinalysis	Urinalysis assessments will include assessments of microalbuminuria and microalbuminuria to creatinuria ratio. A spot urine sample will be collected from first morning void.
DIAGNOSTIC_TEST	Anthropometric measures and vitals signs	weight, height and blood pressure will be assessed

Timeline

• Start date: 2017-11-30
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2017-07-02
• Last updated: 2018-07-05

Locations

1 site across 1 country: Belgium