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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02431416
Other study ID # OLL-430981
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date September 2018

Study information

Verified date March 2019
Source Region Örebro County
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date September 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Female
Age group 1 Year and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Gonadotropin releasing hormone (GnRH)
Gonadotropin releasing hormone GnRH (Relefact LHRH) iv injection, single dose, 100 micrograms/square meter body surface, maximum dose: 100 microgram.
Sodium Chloride
Sodium chlorid 9 mg/mL will be given as a single iv injection with the same volume as the volume used for the active substance injection.

Locations

Country Name City State
Sweden Department of Paediatrics, Örebro University Hospital Örebro

Sponsors (2)

Lead Sponsor Collaborator
Region Örebro County Uppsala-Örebro Regional Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ghrelin concentration after GnRH injection and after saline injection Paired comparison will be done between the acylated ghrelin concentration after GnRH injection and the acylated ghrelin concentration after saline injection.
Paired comparison will also be done between deacylated ghrelin concentration after GnRH injection and deacylated ghrelin concentration after saline injection.
30-150 min after iv injections
Secondary 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 Concentrations of deacylated ghrelin will be compared between different handling procedures. At baseline
Secondary 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 Deacylated ghrelin concentrations will be compared at 150 min after iv injections between different handling procedures. 150 min after iv injections
Secondary Acylated ghrelin concentrations in samples treated with and without hydrochloric acid Acylated ghrelin concentrations will be compared between different handling procedures. 0-150 min after iv injections
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