Adrenal Function in GHD Children

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

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

Study Overview

• Status: Completed
• Conditions: Growth Hormone Treatment; Adrenal; Functional Disturbance
• Intervention / Treatment: Drug: growth hormone

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90127
    • Endocrinology - University of Palermo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

30 consecutive children with short stature and overt idiopathic GHD and 30 children with constitutional short stature without endocrine disease

Description

Inclusion Criteria:

• prepubertal children with overt idiopathic growth hormone deficiency

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GHD children; about 30 prepubertal children affected by overt idiopathic GHD	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.
controls; about 30 prepubertal children with constitutional short stature without endocrine disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Palermo

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2016
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): May 30, 2017

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (ACTUAL): June 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: children; growth hormone; adrenal function
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: UPalermo ITT-GHD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be available just for our study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No