NCT03033121

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Palermo · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Growth Hormone Treatment

Interventions

Type	Name	Description
DRUG	Growth Hormone

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2017-01-26
• Last updated: 2017-10-27

Locations

1 site across 1 country: Italy