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De rol van hypocretine in het aansturen van eetgedrag


- candidate number17372
- NTR NumberNTR4508
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-apr-2014
- Secondary IDsNL45550.091.13 CMO
- Public TitleDe rol van hypocretine in het aansturen van eetgedrag
- Scientific TitleThe role of hypocretin in food-related motivation and self-control: a fMRI study in narcolepsy patients
- ACRONYM
- hypothesisAbnormal food-related motivation and self-control accompanied by aberrant brain responses are related to deficient hypocretin levels in narcolepsy patients and not found in sleepy patients with normal hypocretin levels.
- Healt Condition(s) or Problem(s) studiedfMRI, Eating behaviour, Narcolepsy, Hypocretin
- Inclusion criteria- Age: 18-60 years old
- Right-handed
- BMI-range between 20-35.
Control group:
- No current sleep, neurological or psychiatric disorder
- Will be matched on age and BMI (range 20-35) with patient groups
Patient groups:
- Narcolepsy with cataplexy, or primary hypersomnia (either narcolepsy without cataplexy or idiopathic hypersomnia without long sleep time). All disorders should have been diagnosed according to the International Classification of Sleep Disorders Second Edition (ICSD-2) criteria (American_Academy_of_Sleep_Medicine, 2005).
- All patients who take medication should be willing and able to withdraw from taking medication for 1 week.
- Exclusion criteria- Diabetes Mellitus
- (History of) clinically significant hepatic, cardiac, renal, cerebro-vascular, endocrine, metabolic or pulmonary disease
- Uncontrolled hypertension, defined as diastolic blood pressure at rest > 90 mmHg or systolic blood pressure at rest > 160 mmHg
- (History of) clinically significant neurological or psychiatric disorders and current psychological treatment other than narcolepsy or idiopathic hypersomnia.
- Deafness, blindness, or sensory-motor handicaps
- History of taste or smell impairments
- Drug, alcohol or gamble addiction in the past 6 months
- Inadequate command of Dutch language
- Extreme restraint eating (i.e. score restraint eating ≥3.60 (females) or ≥ 4.00 (males) on the Dutch Eating Behaviour Questionnaire; see also section 6.3.4)
- Current, strict dieting (i.e. specific diet and/or in treatment with dietician)
- Food allergy to one of the ingredients used in the food rewards
- Contra-indications for MRI:
o Metal objects or fragments in the body that cannot be taken out
o Active implants in the body
o Using medical plasters
o Epilepsy
o Previous head surgery
o Pregnancy
o Claustrophobia
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 7-jan-2014
- planned closingdate
- Target number of participants60
- InterventionsThis is an observational study in which fMRI and behavioural tasks are used.
- Primary outcome- Function MRI images
- Behavioural data
- Questionnaires
- Secondary outcomeActual food intake
- Timepoints1
- Trial web sitewww.allesovernarcolepsie.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Ruth Holst, van
- CONTACT for SCIENTIFIC QUERIES Ruth Holst, van
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
NWO (VIDI grant)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD11-apr-2014 - 5-mei-2014


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