To evaluate the effects of intranasal oxytocin compared to placebo administration on appetite, satiety and food intake.Also effects on social behavior, BMI, body composition, IGF-I levels and genetic differences (deletion / mUPD). To assess oxytocin…
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Change 4 weeks oxytocin versus 4 week placebo on eating behaviour (Dykens
hyperphagia questionnaire)
- Difference in eating behaviour between start and after 6 months of oxytocin
nasal spray (Dykens hyperphagia questionnaire)
Secondary outcome
Change 4 weeks oxytocin versus 4 week placebo on:
- Body composition (Anthropometric measurements, BMI and DXA-scan)
- Eating behaviour (questionnaire about behaviour and pancake test)
- Social behaviour (Questionnaire about behaviour for parents and Theory of
Mind test)
- fMRI (BOLD responses) in children >6 years
- Laboratory parameter (oxytocin in saliva and blood)
- Safety parameters (laboratory parameters and medical assessments).
Effects of 6 months oxytocin nasal spray on:
- Body composition (Anthropometric measurements, BMI and DXA-scan)
- Eating behaviour (questionnaire about behaviour and pancake test)
- Social behaviour (Questionnaire about behaviour for parents and Theory of
Mind test)
- fMRI (BOLD responses) in children >6 years
- Laboratory parameter (oxytocin in saliva and blood)
- Safety parameters (laboratory parameters and medical assessments).
Background summary
Patients with PWS are at risk for morbid obesity. Preliminary studies
demonstrated hypothalamic and oxytocinergic dysfunction in patients with PWS.
The number of oxytocin-expressing neurons in the PVN of patients with PWS is
significantly decreased with 42%. Recent studies in human found positive
effects of oxytocin on weight balance and social behavior. The oxytocin system
is a promising target for therapeutic interventions, especially in obesity
control and in aberrations in social function. A pilot study with intranasal
oxytocin administration in adults with PWS showed positive effects on social
behavior. The aim of this study is to investigate the effects of intranasal
oxytocin administration on body composition and social and eating behavior in
children and young adults with PWS.
Study objective
To evaluate the effects of intranasal oxytocin compared to placebo
administration on appetite, satiety and food intake.
Also effects on social behavior, BMI, body composition, IGF-I levels and
genetic differences (deletion / mUPD). To assess oxytocin levels in blood and
saliva samples before, during and after oxytocin treatment compared with
placebo.
In the 6 months open-label extension the long-term effects of intanasal
oxytocin on appetite, satiety and food intake will be investigated. Also
effects on social behavior, BMI, body composition, IGF-I levels and genetic
differences (deletion/mUPD) will be assessed. Oxytocin levels in blood and
saliva samples will be assessed before and after 6 months of oxytocin
treatment.
Study design
- Original study: Randomized, double-blind, placebo controlled cross-over
intervention study.
- Amendment: 6 months open-label extension to the original study.
Intervention
Cross-over intervention with intranasal administration of oxytocin and placebo,
both during 4 weeks. Dose dependent on body surface; 24 IU/m2/day in 2 doses
per day. During the 6 months open-label extension all children will be treated
with oxytocin nasal spray.
Study burden and risks
Burden: Administration of intranasal oxytocin and placebo, both 2 times a day
during 4 weeks. Three hospital visits with a blood sample, DXA-scan, fMRI and
psychological test. A short diary about behaviour have to be filled out daily.
Patients and their parents are highly motivated to participate in this study
because all caregivers want to find a treatment against the hyperphagia problem
and morbid obesity in these patients.
If patients decide to participate in the open-label extension, treatment with
oxytocin nasal spray will be continued for 6 months. Also, a fourth hospital
visit will be planned.
Risks: Based on studies with a single gift oxytocin and studies with longterm
oxytocin (fewer), we conclude that the side effects are mild and the risks are
minimal.
Westzeedijk 106
Rotterdam 3016AH
NL
Westzeedijk 106
Rotterdam 3016AH
NL
Listed location countries
Age
Inclusion criteria
Children with Prader-Willi syndrom, genetically confirmed diagnosis
Age between 6 and 14 years
Exclusion criteria
- Severe psychiatric problems
- Non cooperative behaviour
- Allergic reactions or hypersensitivity for oxytocin
- Serious illness
- Cardiac abnormalities
- Extremely low dietary intake of less than minimal required intake according to WHO
- Medication to reduce weight (fat)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-004134-15-NL |
| CCMO | NL46485.078.14 |