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

Metabolic differences between narcoleptic patients and healthy controls, and the effect of sodium oxybate in patients - Metabolism and Sodium Oxybate in Narcolepsy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31397

Enrollment

Registered

2008-03-20

Start date

2008-01-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Narcolepsy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Countries

Netherlands

Outcome results