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

Phase 3

Completed

• Conditions: Growth Hormone Treatment
• Interventions: Drug: Growth Hormone

• Registration Number: NCT03033121
• Lead Sponsor: University of Palermo

Brief 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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Study First Submitted: 2017-01-18
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-26
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	Growth Hormone	Sixteen growth hormone (GH) deficiency children were assigned to receive daily growth hormone therapy for 12 months. The investigators used an initial weekly dose of 0.175 mg/kg (corresponding to the daily dose of 0.025 mg/Kg) of GH with a gradual increase every 6 months in order to always maintain the insulin growth factor (IGF)-I levels in the normal range. In detail, from months 1 to 6 the investigators used the mean weekly dose of 0.175 mg/kg and from months 6 to 12 the mean weekly dose of 0.20 mg/kg.
group B	Growth Hormone	Sixteen growth hormone (GH) deficiency children were assigned to receive three time weekly growth hormone therapy for 12 months. The investigators used an initial weekly dose of 0.175 mg/kg (corresponding to the daily dose of 0.025 mg/Kg) of GH with a gradual increase every 6 months in order to always maintain the insulin growth factor (IGF)-I levels in the normal range. In detail, from months 1 to 6 the investigators used the mean weekly dose of 0.175 mg/kg and from months 6 to 12 the mean weekly dose of 0.20 mg/kg.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Endocrinology - University of Palermo; 🇮🇹 Palermo, Italy