Growth Hormone Treatment
Conditions
Keywords
growth hormone, children, metabolism
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.
Interventions
DRUGGrowth Hormone
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glycated hemoglobin | 12 months | glycated hemoglobin (%) |
| ISI Matsuda | 12 months | Insulin Sensitivity Index |
| Oral disposition index | 12 months | Oral Disposition Index (DIo) |
| Homa IR | 12 months | The homeostatic model assessment of insulin resistance |
| LDL cholesterol | 12 months | Low Density Lipoprotein cholesterol (mmol/l) |
| Triglycerides | 12 months | triglycerides (mmol/l) |
| height | 12 months | height (standard deviation) |
| weight | 12 months | weight (kilograms) |
| body mass index | 12 months | body mass index (kilograms/m2) |
| 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 |
Countries
Italy
Outcome results
None listed