Growth Hormone Treatment Clinical Trial
— GH 3 wk doseOfficial title:
More Favorable Metabolic Impact of Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children
Verified date | October 2017 |
Source | University of Palermo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | January 1, 2017 |
Est. primary completion date | January 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Endocrinology - University of Palermo | Palermo |
Lead Sponsor | Collaborator |
---|---|
University of Palermo |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | height | height (standard deviation) | 12 months | |
Primary | weight | weight (kilograms) | 12 months | |
Primary | body mass index | body mass index (kilograms/m2) | 12 months | |
Primary | Insulin growth factor-I | insulin growth factor (IGF)-I (ug/L) | 12 months | |
Primary | glucose | glucose (mmol/l) during oral glucose tolerance test | 12 months | |
Primary | insulin | insulin (uU/ml) during oral glucose tolerance test | 12 months | |
Primary | glycated hemoglobin | glycated hemoglobin (%) | 12 months | |
Primary | ISI Matsuda | Insulin Sensitivity Index | 12 months | |
Primary | Oral disposition index | Oral Disposition Index (DIo) | 12 months | |
Primary | Homa IR | The homeostatic model assessment of insulin resistance | 12 months | |
Primary | LDL cholesterol | Low Density Lipoprotein cholesterol (mmol/l) | 12 months | |
Primary | Triglycerides | triglycerides (mmol/l) | 12 months |
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