Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children — GH 3 wk dose  

Growth Hormone Treatment Clinical Trial

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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Growth Hormone Treatment

• NCT number: NCT03033121
• Study type: Interventional
• Source: University of Palermo
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2016
• Completion date: January 1, 2017