Clinical trial NCT02431416: Effect of a GnRH Injection on Ghrelin Concentrations in Girls With Suspected Premature Puberty
Official title: Effect of a GnRH Injection on Ghrelin Concentrations in Girls With Suspected Precocious Puberty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Puberty, Precocious
Keywords: females
ghrelin
GnRH
randomized, controlled study
children
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Uppsala-Örebro Regional Research Council
First posted: 2015-05-01
Enrollment: 13
Sex: FEMALE
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purposes of the study is to investigate whether circulating levels of ghrelin decreases after an iv injection of GnRH in girls with suspected central premature puberty and to investigate the effects of different post sampling handling on the preservation of acylated ghrelin.

Detailed description: Patients with clinically suspected central premature puberty undergo a GnRH stimulation test to have an appropriate diagnosis. 20 such girls will be recruited to this study and a modified GnRH stimulation test will be done. The modification includes prolonged blood sampling time (0, 30, 60, 90, 120, and 150 min after the GnRH injection instead of the usual 0, 30, 60, and 90 min). The girls will also be investigated twice. In randomised order they will be given either GnRH or placebo (isotone saline), on different days. One week to one month will separate the different investigation days.

The proteinase inhibitor 4-(2-aminoethyl) benzene-sulfonyl fluoride hydrochlorid (AEBSF) will be added to some of the blood tubes, and hydrochloric acid will be added to some of the plasma. All plasma samples will be frozen and all analyses will be done at the same time. Acylated ghrelin will be analyzed by Millipore's specific ELISA kit and deacylated ghrelin will be analyzed by Cayman's specific ELISA kit.

Anthropometric data as well as pubertal state will be collected. P-glucose, S-insulin, S-follicle stimulating hormone (FSH), S-luteinizing hormone (LH), and S-estradiol will also be analyzed.

Eligibility criteria: Inclusion Criteria:

* Female gender.
* Clinical suspicion of central precocious puberty.
* A GnRH stimulation test is to be performed to make appropriate diagnosis.

Exclusion Criteria:

* Age \< 1 year.
* Weight \< 10 kg.
* Untreated hypo- or hyperthyroidism.
* Diabetes of any kind.
* BMI \> 3 z-score.
* Growth hormone treatment.
* Syndrome or suspected syndrome.
* Tumour or congenital malformation of the hypothalamus or the pituitary gland. (Neuroradiology does not have to be performed only because of the study.)
* On going ulcus ventriculi or the patient has gone through surgery that removed part of the ventricle or changed it markedly in any other way.

Primary outcomes:
measure: Ghrelin concentration after GnRH injection and after saline injection
timeFrame: 30-150 min after iv injections
Secondary outcomes:
measure: Deacylated ghrelin concentrations in samples treated with the inhibitor AEBSF, in samples treated with both AEBSF and hydrochloric acid, and in samples not treated with either AEBSF or hydrochloric acid
timeFrame: At baseline
measure: Deacylated ghrelin concentrations in samples treated with the inhibitor AEBSF, in samples treated with both AEBSF and hydrochloric acid, and in samples not treated with either AEBSF or hydrochloric acid
timeFrame: 150 min after iv injections
measure: Acylated ghrelin concentrations in samples treated with and without hydrochloric acid
timeFrame: 0-150 min after iv injections
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Department of Paediatrics, Örebro University Hospital
Study officials:
affiliation: Department of Paediatrics, Faculty of Medicine and Health, Örebro University
name: Maria Lodefalk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: