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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Region Örebro County

Current Primary Outcome: Ghrelin concentration after GnRH injection and after saline injection [ Time Frame: 30-150 min after iv injections ]

Original Primary Outcome: Comparison between ghrelin concentration after GnRH injection and ghrelin concentration after saline injection [ Time Frame: 30-150 min after iv injections ]

Current Secondary Outcome:

• 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 [ Time Frame: At baseline ]
• 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 [ Time Frame: 150 min after iv injections ]
• Acylated ghrelin concentrations in samples treated with and without hydrochloric acid [ Time Frame: 0-150 min after iv injections ]

Original Secondary Outcome:

• Comparison between 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 [ Time Frame: At baseline ]
• Comparison between 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 [ Time Frame: 150 min after iv injections ]
• Comparison between acylated ghrelin concentrations in samples treated with and without hydrochloric acid [ Time Frame: 0-150 min after iv injections ]

Information By: Region Örebro County

Dates:
Date Received: April 10, 2015
Date Started: May 2015
Date Completion: December 2017
Last Updated: April 19, 2017
Last Verified: April 2017