Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children

Growth Hormone Treatment Clinical Trial

— GH 3 wk dose  

Official title:

More Favorable Metabolic Impact of Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033121
• Other study ID #: 3-wk-GH
• Status: Completed
• Phase: Phase 3
• First received: January 18, 2017
• Last updated: October 25, 2017
• Start date: January 1, 2016
• Est. completion date: January 1, 2017

Study information

• Verified date: October 2017
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is often not complied. The auxological effect of three injections per week (TIW) regimen is controversial, while the metabolic effects were never evaluated in children. The objective of this study was to evaluate whether two different regimens of weekly injections could lead to similar auxological and metabolic effects in children with GHD.

Description:

Thirty-two children with growth hormone (GH) deficiency (25 males, mean age 10.5 ± 2.2 yr) were randomly assigned to receive daily (group A, No 16) or three injections per week (group B, No 16) GH therapy for 12 months.

Auxological parameters, insulin-like growth factor-I (IGF-I), glucose and insulin during an oral glucose tolerance test, glycosylated hemoglobin, lipid profile, the oral disposition index (DIo), the homeostasis model assessment estimate of insulin resistance (Homa-IR), the quantitative insulin sensitivity check index (QUICKI) and the insulin sensitivity index (ISI) were evaluated in the two groups of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Growth hormone deficiency clinically and biochemically demonstrated

Exclusion Criteria:

• Children affected by multiple pituitary hormone deficiency or receiving any other kind of hormonal replacement therapy or drug and GHD children with a shorter follow-up

Related Conditions & MeSH terms

• Growth Hormone Treatment

Intervention

Drug:
• Growth Hormone

Locations

Country	Name	City	State
Italy	Endocrinology - University of Palermo	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	height	height (standard deviation)	12 months
Primary	weight	weight (kilograms)	12 months
Primary	body mass index	body mass index (kilograms/m2)	12 months
Primary	Insulin growth factor-I	insulin growth factor (IGF)-I (ug/L)	12 months
Primary	glucose	glucose (mmol/l) during oral glucose tolerance test	12 months
Primary	insulin	insulin (uU/ml) during oral glucose tolerance test	12 months
Primary	glycated hemoglobin	glycated hemoglobin (%)	12 months
Primary	ISI Matsuda	Insulin Sensitivity Index	12 months
Primary	Oral disposition index	Oral Disposition Index (DIo)	12 months
Primary	Homa IR	The homeostatic model assessment of insulin resistance	12 months
Primary	LDL cholesterol	Low Density Lipoprotein cholesterol (mmol/l)	12 months
Primary	Triglycerides	triglycerides (mmol/l)	12 months