Predictive diagnostic study on the short-term metabolic effects of recombinant human Growth Hormone treatment in growth hormone deficiency and small for gestational age children.
- Conditions
- growth hormone deficiency / insufficiency10021112
- Registration Number
- NL-OMON36604
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
All children scheduled for growth hormone treatment, fulfilling the next criteria: ;#Children born small for gestational age (SGA) without catch up growth:
- Children born with a birth length and/or weight < -2 SDS for gestational age
- Short stature defined as height SDS below -2.5 according to the Dutch National Growth ;#Children with growth hormone deficiency (GHD):
- GHD is confirmed in all patients who during an arginine and clonidine provocation test show a peak GH level of < 20 mU/l. ;#Age equal to or above four years.
- Children with a chronological or bone age greater than 8 years for girls and 10 years for boys, because of the influence of puberty
- Children with syndromes or diseases that influence growth otherwise than GDH or SGA.
- Expected non-compliance
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The relation between short time effects of rhGH treatment on total body water<br /><br>(TBW) and total energy expenditure (TEE) in growth hormone deficient and small<br /><br>for gestational age children and the long-term change in height SDS after one<br /><br>year.</p><br>
- Secondary Outcome Measures
Name Time Method <p>What effect has GH on a number of metabolic risk parameters that are typical<br /><br>parameters for the metabolic syndrome in adults?</p><br>