Sebum Measurement in Newborn to Detect Hyperexposure to Androgens

Status Recruiting

Clinical Trial Summary

The source of PCOS is unknown. Our hypothesis is that over exposure to testosterone of the foetus in utero alters the expression of genes thought to be involved in the cause of PCOS.

Clinical Trial Description

Polycystic ovary syndrome (PCOS) affecting 10-15% of the female population causes excess hair, acne, irregular/absent ovulation, infertility and is associated with hypertension, diabetes, heart attacks and stroke in later life. The economic care-related burden of the syndrome is estimated at $4.36 billion/year in the USA. The root cause is unknown and although mostly familial, the offending genes are unknown. We believe that excess testosterone, to which the foetus is exposed during its life in the womb, causes development of PCOS in adult life. If a mother with PCOS exposes her foetus to high testosterone levels compared to one with no PCOS, this would be the first step in proving the developmental hypothesis for PCOS, opening the door to methods to prevent the appearance of the distressing symptoms of PCOS in adult life. With no access to the foetal environment, we have used the surrogate measure of sebum on the skin of the newborn, 99% influenced by testosterone. Our pilot study (Homburg et al, 2017) used absorbent paper to measure sebum excretion in PCOS and controls within 24 hours and 1-24 weeks after birth in mother and baby. Higher sebum production in female babies of PCOS mothers strongly supported our hypothesis. The present proposal utilizes a 30-second, non-invasive, quantitative measurement of sebum (Sebumeter®) in the newborn from PCOS mothers and controls, within 24 hours of birth. We will correlate results with other features in both female and male newborn that may suggest hyper-exposure to testosterone and with maternal testosterone levels in the blood. If confirming the findings of our pilot study in line with the developmental theory of PCOS, this could be used within 24 hours of birth to predict development of PCOS in adult life, induce measures to prevent the symptoms of PCOS and reduce the enormous health burden on patients and economies ;

Study Design

Related Conditions & MeSH terms

Polycystic Ovary Syndrome

Clinical Trial Details

NCT number	NCT04065100
Study type	Interventional
Source	Homerton University Hospital NHS Foundation Trust
Contact	Roy Homburg
Phone	07484608134
Email	royhomburg@gmail.com
Status	Recruiting
Phase	N/A
Start date	July 8, 2019
Completion date	December 31, 2022

View Details

See also
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Not yet recruiting	`NCT00883259` - Metformin and Gestational Diabetes in High-risk Patients: a RCTs	Phase 4
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Completed	`NCT01462864` - Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.