Effects of growth hormone treatment after final height in Prader-Willi Syndrome

Effects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28633

Enrollment

Registered

2007-08-16

Start date

2007-10-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Prader-Willi Syndrome Prader-Willi Syndroom

Interventions

Treatment with GH: Genotropin 0.67 mg/m2/day s.c. or placebo

Eligibility

Inclusion criteria

Inclusion criteria: 1. Young adults, originally participating in the Dutch GH study in PWS children (ISRCTN49726762) or otherwise GH-treated patients and 2. Final height is reached or epiphysial fusion is complete and 3. Treated with GH during childhood for at least 2 years

Exclusion criteria

Exclusion criteria: 1. non cooperative behaviour 2. extremely low dietary intake of less than minimal required intake according to WHO 3. medication to reduce weight (fat)

Design outcomes

Primary

Measure	Time frame
To assess effects of GH-treatment versus placebo on a. body composition b. carbohydrate metabolism c. psychosocial functioning d. sleep-related breathing disorders e. circulating lipids f. blood pressure	—

Secondary

Measure	Time frame
1. To study the effects of GH-treatment versus placebo on thyroid hormone levels, IGF-I and IGF binding proteins, adiponectin, ghrelin. 2. To study compliance to the diet.	—

Contacts

Public ContactDederieke Festen

Dutch Growth Foundation, Westzeedijk 106

d.festen@erasmusmc.nl+31 (0)10 2251533

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)