Effect of sodium oxybate on brown adipose tissue activity in narcolepsy
- Conditions
- hypersomnieënhypersomnianarcolepsy1002111210013317
- Registration Number
- NL-OMON48148
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
Patients:
1. Narcolepsy type 1 based on ICSD-3 criteria.
2. *18 and <40 years of age.
3. White Caucasian descent.
4. Clinical indication for sodium oxybate treatment.
5. BMI * 27 kg/m2, Healthy controls:
1. Age-, gender- and BMI-match with patient.
Patients and healthy controls:
1. Smoking.
2. Renal, hepatic or endocrine disease.
3. Previous use of sodium oxybate.
4. Use of medication known to influence glucose and/or lipid metabolism or
brown adiposue tissue activity (e.g. *-adrenergic receptor blockers).
5. Participation in an intensive weight-loss program or vigorous exercise
program during the year before the start of the study.
6. Contraindications for sodium oxybate treatment.
7. Contraindications for undergoing an MRI scan:
- Presence of non-MR safe metal implants or objects in the body.
- Pacemaker, neurostimulator, hydrocephalus pump, drug pump, non-removable
hearing aid, large recent tattoos.
- Claustrophobia
- Tinnitus or hyperacusis
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Cold-induced BAT volume and activity: measured by individualized cooling<br /><br>followed by 18F-FDG PET-CT scan in healthy controls and in narcolepsy type 1<br /><br>patients before and after 3 weeks of SXB treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Resting energy expenditure: measured by indirect calorimetry in healthy<br /><br>controls and in narcolepsy type 1 patients before, after 1 day and after 3<br /><br>weeks of SXB treatment.<br /><br>- Skin temperature: measured by wireless iButtons in healthy controls and in<br /><br>narcolepsy type 1 patients before, after 1 day and after 3 weeks of SXB<br /><br>treatment.<br /><br>- Thermoneutral and cold-induced lipoprotein dynamics in healthy controls and<br /><br>in narcolepsy type 1 patients before and after 3 weeks of SXB treatment.<br /><br>- Fat/lean mass loss: measured by bioelectrical impedance analysis measurement.<br /><br>- Thermoneutral BAT volume and fat fraction: measured by MRI scan in<br /><br>thermoneutral condition in healthy controls and in narcolepsy type 1 patients<br /><br>before and after 3 weeks of SXB treatment.</p><br>