Proteinuria Clinical Trial
Official title:
The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children
Verified date | April 2019 |
Source | Tel-Aviv Sourasky Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The presence of protein in urine is a common laboratory finding in children. Although
proteinuria is usually benign, it can be a marker of a serious underlying renal disease or
systemic disorder. Microalbuminuria can be one of the first subclinical manifestations of
endothelial dysfunction and is associated with low grade systemic inflammation. Multiple
studies from the adult population suggest that microalbuminuria above the upper quartile is
linked with increased risk of coronary heart disease and death even after adjustment for the
presence of diabetes mellitus, obesity and hypertension.
Obstructive sleep apnea (OSA) has been recognized as an independent risk factor for
cardiovascular morbidity related to sympathetic nervous system overflow, metabolic
dysregulation, inflammation and endothelial dysfunction secondary to repetitive hypoxia
-reoxygenation events.
Therefore, there is a need for further studies to investigate the association between OSA and
microalbuminuria in children. Furthermore, no studies have thus far investigated the
association between other sleep disorders such as periodic limb movement (PLMD) and
microalbuminuria in children.
Our hypothesis is that children with sleep disorders or short sleep duration have increased
risk of proteinuria/microalbuminuria and that treatment and resolution of the sleep problem
will be followed by improvement in proteinuria levels.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | September 1, 2021 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 17 Years |
Eligibility |
Inclusion Criteria: 1. age: 2-17 years 2. Referred to overnight PSG due to suspected OSA or PLMD 3. referred for evaluation in the nephrology clinic due to proteinuria Exclusion Criteria: 1. Known renal disease; 2. diabetes mellitus; 3. current use of ACE inhibitors or angiotensin receptor blockers; 4. neuromuscular disorders 5. craniofacial abnormalities 6. syndromic conditions. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | morning urine protein/creatinine >0.2 | 1 year | ||
Primary | reported sleep duration (hours) | 1 year | ||
Primary | morning urine protein/creatinine >0.2 post treatment of OSA | 1 year |
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