Adrenal Function in GHD Children

Sponsor

University of Palermo (Other)

Overall Status

Completed

CT.gov ID

NCT03203356

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Treatment Adrenal; Functional Disturbance	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 Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 30, 2016

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

May 30, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Evaluation of adrenal function in GHD children at baseline and in control group [baseline]
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
Change in adrenal function in GHD children during GH therapy [6 and 12 months]
We will evaluate through insulin tolerance test the response of serum cortisol levels in GHD children after 6 and 12 months of GH therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

prepubertal children with overt idiopathic growth hormone deficiency

Exclusion Criteria:

Children with organic growth hormone deficiency or under treatment with glucocorticoids

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endocrinology - University of Palermo	Palermo		Italy	90127

Sponsors and Collaborators

University of Palermo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carla Giordano, Prof. Carla Giordano, University of Palermo

ClinicalTrials.gov Identifier:

NCT03203356

Other Study ID Numbers:

UPalermo ITT-GHD

First Posted:

Jun 29, 2017

Last Update Posted:

Jun 29, 2017

Last Verified:

Jun 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Carla Giordano, Prof. Carla Giordano, University of Palermo

growth hormone

children

adrenal function

Additional relevant MeSH terms:

Hormones

Study Results

No Results Posted as of Jun 29, 2017