Adrenal Function in GHD Children

Growth Hormone Treatment Clinical Trial

Official title:

Evaluation of Adrenal Function Before and After GH Treatment in GHD Affected by GH Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203356
• Other study ID #: UPalermo ITT-GHD
• Status: Completed
• Phase: N/A
• First received: May 26, 2017
• Last updated: June 27, 2017
• Start date: May 30, 2016
• Est. completion date: May 30, 2017

Study information

• Verified date: June 2017
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate in children affected by idiopathic GHD the adrenal function both at baseline and after 6 and 12 months of GH treatment.

Description:

The relationship between the growth hormone (GH)-insulin like growth factor (IGF)-I system and the hypothalamic-pituitary-adrenal (HPA) axis is complex and not univocal. Both a stimulatory and neutral effect of IGF-I on HPA axis has been demonstrated in in vitro models and in healthy subjects, respectively. The effect of GH on the 11beta-hydroxysteroid dehydrogenases (11beta-HSD) isozymes is always to be considered in patients affected by GHD both at diagnosis and during GH treatment. Indeed, in peripheral tissues, corticosteroid hormone action is partially determined by the activity of 11beta-HSD, two isozymes of which interconvert hormonally active cortisol and inactive cortisone. 11beta-HSD2 inactivates cortisol to cortisone in the kidney, whilst 11beta-HSD1 performs the reverse reaction activating cortisol from cortisone in the liver and adipose tissue.

For these reasons, many data are available about the evaluation of adrenal function in patients affeceted byGHD, but most of them come from patients with organic GHD or adult patients, while few and discordant data are available on pediatric GHD patients. We aimed to evaluate, through insulin tolerance test, the adrenal function in about 30 children with overt diagnosis of idiopathic GHD both at baseline and after 6 and 12 months of GH treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 30, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• prepubertal children with overt idiopathic growth hormone deficiency

Exclusion Criteria:

• Children with organic growth hormone deficiency or under treatment with glucocorticoids

Related Conditions & MeSH terms

• Adrenal; Functional Disturbance
• Growth Hormone Treatment
• Pathologic Processes

Intervention

Drug:
• growth hormone
Children with a diagnosis of GHD will practice GH replacement therapy in line with normal clinical practice and international guidelines. Controls will be evaluated just at baseline.

Locations

Country	Name	City	State
Italy	Endocrinology - University of Palermo	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of adrenal function in GHD children at baseline and in control group	We will evaluate through insulin tolerance test the response of serum cortisol levels in GHD children at diagnosis (before start of GH therapy) and in controls subjects	baseline
Primary	Change in adrenal function in GHD children during GH therapy	We will evaluate through insulin tolerance test the response of serum cortisol levels in GHD children after 6 and 12 months of GH therapy	6 and 12 months