Metabolic differences between narcoleptic patients and healthy controls, and the effect of sodium oxybate in patients

• Conditions: Narcolepsy; 10040998

• Registration Number: NL-OMON31397
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

-male and age between 18 and 65 years.
- Patients: sporadic narcolepsy with cataplexy (according to ICSD-2 criteria), undetectable hypocretin-1 levels in the CSF.
- Eligible for sodium oxybate treatment

Exclusion Criteria

- hypertension (BP systolic > 165 or diastolic > 95 mm Hg)
- any (history of) pituitary, psychiatric or neurological disease
- diabetes mellitus (fasting plasma glucose > 6.9 mm/l)
- alcohol /drug abuse
- anemia

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Is there difference in energy expenditure between narcolepsy patients and<br /><br>healthy<br /><br>controls?<br /><br><br /><br>2. Is there difference in insulin sensitivity between patients with narcolepsy<br /><br>and healthy controls?<br /><br><br /><br>3. What is the impact of chronic sodium oxybate treatment (3-4 months) on these<br /><br>(above)<br /><br>metabolic features in hypocretin-deficient narcoleptic patients?</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>