Proteinuria Clinical Trial
Official title:
The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children
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.
200 children aged 2-18 years that will be referred to the Sleep Disorders Center for
overnight polysomnography due to suspected sleep disordered breathing or PLMD will be
recruited to the study during their first visit in the sleep clinic. During that study, an
informed consent will be completed by the parents. Data on weekdays and weekends sleep
duration as well as personal and family history of kidney disease will be collected.
Exclusion criteria:1. Known renal disease; 2. diabetes mellitus; 3. current use of ACE
inhibitors or angiotensin receptor blockers; 4. neuromuscular disorders or craniofacial
abnormalities; 5. syndromic conditions.
All participants will undergo physical examination. Weight and height will be measured, and
body mass index (BMI) z-score will be calculated.
Blood pressure will be measured on the first visit in the sleep clinic by a trained physician
as specified in recent guidelines. 19
Overnight polysomnography will be carried out in the Sleep Disorders Laboratory and the
following signals will be recorded: electroencephalogram (EEG; C3/M2, C2/M1, O1/M2, O2/M1);
right and left oculogram; submental and tibial electromyogram; body position;
electrocardiogram; thoracic and abdominal wall motion; oronasal airflow (three-pronged
thermistor and nasal pressure transducer); and oxygen saturation of hemoglobin (SpO2).
Arousals, sleep stages and respiratory events will be scored, and polysomnography indices
will be defined according to the recent American Academy of Sleep Medicine recommendations .
20
First void urine samples will be collected in a sterile cup the morning following the
polysomnography (6:00-7:00 am). For each sample urinalysis, protein/creatinine and
albumin/creatinine will be measured. Urinary albumin and protein excretion will be the
primary outcome measure. Proteinuria will be defined as protein/creatinine greater than 0.2
and albuminuria will be defined as albumin/creatinine above age-adjusted limits Children who
will be diagnosed with moderate-severe OSA will be referred to an ENT surgeon for
adenotonsillectomy, the first line of treatment in pediatric OSA. Six to 10 weeks following
surgery, these children will be requested to undergo additional PSG evaluation. First void
urine samples will be collected the following morning.
In addition- 100 children referred to the pediatric nephrology clinic due to asymptomatic
albuminuria/proteinuria will be recruited. Parents will be required to complete a designated
sleep questionnaire that includes items on sleep duration, SDB and RLS symptoms. Exclusion
criteria, as described above for the entire cohort, will also apply to this subpopulation.
Informed consent will be completed by the parents.
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