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Adrenal Function in GHD Children

NCT ID: NCT03203356

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-30

Study Completion Date

2017-05-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Growth Hormone Treatment Adrenal; Functional Disturbance

Keywords

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growth hormone children adrenal function

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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GHD children

about 30 prepubertal children affected by overt idiopathic GHD

growth hormone

Intervention Type DRUG

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

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* prepubertal children with overt idiopathic growth hormone deficiency

Exclusion Criteria

* Children with organic growth hormone deficiency or under treatment with glucocorticoids
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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Carla Giordano

Prof. Carla Giordano

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Endocrinology - University of Palermo

Palermo, , Italy

Site Status

Countries

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Italy

Other Identifiers

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UPalermo ITT-GHD

Identifier Type: -

Identifier Source: org_study_id