NCT02431416

Effect of a GnRH Injection on Ghrelin Concentrations in Girls With Suspected Premature Puberty

Effect of a GnRH Injection on Ghrelin Concentrations in Girls With Suspected Precocious Puberty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Region Örebro County · Academic / Other
• Sex: Female
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• Puberty, Precocious

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-12-01
• Completion: 2018-09-01
• First posted: 2015-05-01
• Last updated: 2019-04-01

Locations

1 site across 1 country: Sweden