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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Growth Hormone Treatment

Intervention / Treatment
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* Drug: Growth Hormone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>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. | Drug: Growth Hormone<br> <br> |
| Active Comparator: group B<br>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. | Drug: Growth Hormone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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growth hormone, children, metabolism