Puberty, Precocious Clinical Trial
Official title:
Effect of a GnRH Injection on Ghrelin Concentrations in Girls With Suspected Precocious Puberty
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 |
Verified date | March 2019 |
Source | Region Örebro County |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Paediatrics, Örebro University Hospital | Örebro |
Lead Sponsor | Collaborator |
---|---|
Region Örebro County | Uppsala-Örebro Regional Research Council |
Sweden,
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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