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Effect of sodium oxybate on brown adipose tissue activity in narcolepsy

Effect of sodium oxybate on brown adipose tissue activity in narcolepsy - Sodium oxybate and brown adipose tissue in narcolepsy

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48148
Enrollment
20
Registered
2019-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

hypersomnieën hypersomnia narcolepsy

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: 1. Narcolepsy type 1 based on ICSD-3 criteria. 2. *18 and

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Cold-induced BAT volume and activity: measured by individualized cooling followed by 18F-FDG PET-CT scan in healthy controls and in narcolepsy type 1 patients before and after 3 weeks of SXB treatment.

Secondary

MeasureTime frame
- Resting energy expenditure: measured by indirect calorimetry in healthy controls and in narcolepsy type 1 patients before, after 1 day and after 3 weeks of SXB treatment. - Skin temperature: measured by wireless iButtons in healthy controls and in narcolepsy type 1 patients before, after 1 day and after 3 weeks of SXB treatment. - Thermoneutral and cold-induced lipoprotein dynamics in healthy controls and in narcolepsy type 1 patients before and after 3 weeks of SXB treatment. - Fat/lean mass loss: measured by bioelectrical impedance analysis measurement. - Thermoneutral BAT volume and fat fraction: measured by MRI scan in thermoneutral condition in healthy controls and in narcolepsy type 1 patients before and after 3 weeks of SXB treatment.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)