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

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ClinicalTrials.gov Identifier: NCT02431416
Recruitment Status : Completed
First Posted : May 1, 2015
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
Uppsala-Örebro Regional Research Council
Information provided by (Responsible Party):
Region Örebro County

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.

Condition or disease Intervention/treatment Phase
Puberty, Precocious Drug: Gonadotropin releasing hormone (GnRH) Drug: Sodium Chloride Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of a GnRH Injection on Ghrelin Concentrations in Girls With Suspected Precocious Puberty
Actual Study Start Date : May 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : September 2018


Arm Intervention/treatment
Active Comparator: Gonadotropin releasing hormone (GnRH)
A single intravenous injection of gonadotropin releasing hormone GnRH (Relefact LHRH 0,1 mg/mL). Dose: 100 micrograms per square meter body surface. Maximal dose: 100 micrograms.
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.
Other Name: Relefact LHRH

Placebo Comparator: Sodium chloride
A single intravenous injection of sodium chlorid (9 mg/mL). Dose: the same volume as the volume given/to be given with GnRH, that is maximal dose = 1 mL = 9 mg sodium chlorid.
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.
Other Names:
  • Saline
  • placebo




Primary Outcome Measures :
  1. Ghrelin concentration after GnRH injection and after saline injection [ 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.



Secondary Outcome Measures :
  1. 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 ]
    Concentrations of deacylated ghrelin will be compared between different handling procedures.

  2. 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 ]
    Deacylated ghrelin concentrations will be compared at 150 min after iv injections between different handling procedures.

  3. Acylated ghrelin concentrations in samples treated with and without hydrochloric acid [ Time Frame: 0-150 min after iv injections ]
    Acylated ghrelin concentrations will be compared between different handling procedures.



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431416


Locations
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Sweden
Department of Paediatrics, Örebro University Hospital
Örebro, Sweden, 701 85
Sponsors and Collaborators
Region Örebro County
Uppsala-Örebro Regional Research Council
Investigators
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Principal Investigator: Maria Lodefalk, MD, PhD Department of Paediatrics, Faculty of Medicine and Health, Örebro University

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Responsible Party: Region Örebro County
ClinicalTrials.gov Identifier: NCT02431416     History of Changes
Other Study ID Numbers: OLL-430981
First Posted: May 1, 2015    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Region Örebro County:
females
ghrelin
GnRH
randomized, controlled study
children
Additional relevant MeSH terms:
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Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs