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Metabole effecten van groeihormoon.

Predictive diagnostic study on the short-term metabolic effects of rhGH treatment in growth hormone deficiency and small for gestational age children.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24096
Enrollment
30
Registered
2011-05-11
Start date
2011-07-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Growth hormone deficiency Diagnostic problems of growth hormone tests

Interventions

None listed

Sponsors

Maastricht University Medical Centre (MUMC) PO box 5800 6202 AZ Maastricht The Netherlands Telephone +31 43 387 5239
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All children scheduled for growth hormone treatment, fulfilling the next criteria: A. Children born small for gestational age without catch up growth; B. Children born with a birth length and/or weight < -2 SDS for gestational age (Niklasson); C. Short stature defined as height SDS below -2.5 according to the Dutch National Growth References of 1997 and height of &#8805; 1.3 SDS below target height SDS. 2. Children with growth hormone deficiency: A. GHD is confirmed in all patients who during an arginine and clonidine provocation test show a peak GH level of < 20 mU/l. 3. Informed consent; 4. Age &#8805; four years.

Exclusion criteria

Exclusion criteria: 1. Children with a chronological or bone age greater than 8 years for girls and 10 years for boys, because of the influence of puberty; 2. Children younger that 4 years of age; 3. Children with syndromes or diseases that influence growth otherwise than GDH or SGA; 4. Expected non-compliance based on earlier knowledge over the patient by the opinion of the endocrinologist.

Design outcomes

Primary

MeasureTime frame
The relation between short time effects of rhGH treatment on total body water (TBW) and total energy expenditure (TEE) in growth hormone deficient and small for gestational age children and the long-term change in height SDS after one year.

Secondary

MeasureTime frame
What effect has GH on a number of metabolic risk parameters that are typical parameters for the metabolic syndrome in adults?

Contacts

Public ContactD.A. Schott

Department of paediatrics Maastricht University Medical Centre (MUMC) PO box 5800

da.schott@mumc.nl+31 (0)43 3875239

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)