Department of Paediatrics, Örebro University Hospital
Örebro, 701 85, Sweden
NCT Number: NCT02431416
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.
Looking for future studies?
Notify Me1 year and older
Female
Interventional
Not applicable
Örebro, 701 85, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Gonadotropin releasing hormone GnRH (Relefact LHRH) iv injection, single dose, 100 micrograms/square meter body surface, maximum dose: 100 microgram.
Other names: Relefact LHRH
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.
Other names: Saline, placebo
Time frame: 30-150 min after iv injections
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.
Time frame: At baseline
Concentrations of deacylated ghrelin will be compared between different handling procedures.
Time frame: 150 min after iv injections
Deacylated ghrelin concentrations will be compared at 150 min after iv injections between different handling procedures.
Time frame: 0-150 min after iv injections
Acylated ghrelin concentrations will be compared between different handling procedures.
Region Örebro County
Other
Effect of a GnRH Injection on Ghrelin Concentrations in Girls With Suspected Precocious Puberty
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00278915
Bone Diseases, Bone Diseases, Developmental
Birmingham, Alabama, United States
View Trial DetailsNCT00494169
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Boston, Massachusetts, United States
View Trial DetailsNCT04012632
Endocrine System Diseases, Gonadal Disorders
View Trial DetailsNCT00094328
Endocrine System Diseases, Familial Testotoxicosis
Birmingham, Alabama, United States
View Trial Details