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Completed

NCT Number: NCT03203356

Adrenal Function in GHD Children

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

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Key information

Conditions

Growth Hormone Treatment Adrenal; Functional Disturbance

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endocrinology - University of Palermo

Palermo, 90127, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • prepubertal children with overt idiopathic growth hormone deficiency

Exclusion criteria

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

Treatment and study plan

growth hormone

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.

Primary outcomes

  1. Evaluation of adrenal function in GHD children at baseline and in control group

    Time frame: 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

  2. Change in adrenal function in GHD children during GH therapy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2017
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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