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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2019-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Blood Flow and Blood Pressure Investigation in Down Syndrome

NCT05528549

Down Syndrome

COMPLETED PHASE3

Down Syndrome Metabolic Health Study

NCT01821300

Down Syndrome Trisomy 21

COMPLETED

PDA for Kidneys Study

NCT06658496

Patent Ductus Arteriosus Congenital Heart Disease

RECRUITING

Randomized Clinical Trial: Expectant Management vs Laser Treatment of Monochorionic Twins With Severe Selective Intrauterine Growth Retardation and Absent or Reverse Diastolic Flow in the Umbilical Artery

NCT01177553

Intrauterine Growth Retardation

COMPLETED NA

Down Syndrome Autonomic Nervous System Induction Bradycardia

NCT05120531

Down Syndrome Bradycardia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Down Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Interventional controlled cross-sectional study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.