Adrenal Function in GHD Children

NCT03203356 | Completed DMC

• 1 other identifier: UPalermo ITT-GHD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth Hormone Treatment; Adrenal; Functional Disturbance

Keywords

growth hormone; children; adrenal function

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

GHD children

about 30 prepubertal children affected by overt idiopathic GHD

Drug: growth hormone

controls

about 30 prepubertal children with constitutional short stature without endocrine disease

Interventions

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.

GHD children

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• prepubertal children with overt idiopathic growth hormone deficiency

You may not qualify if:

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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Endocrinology - University of Palermo

Palermo, 90127, Italy

Location

MeSH Terms

Interventions

Growth Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Carla Giordano

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: June 29, 2017
• Study Start: May 30, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 30, 2017
• Last Updated: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)