Effect of sodium oxybate on energy metabolism in narcolepsy

Effect of sodium oxybate on energy metabolism in narcolepsy - Sodium oxybate and energy metabolism in narcolepsy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52823

Enrollment

Registered

2020-12-07

Start date

2026-01-22

Completion date

Unknown

Last updated

2026-01-27

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

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patients: 1. Narcolepsy type 1 based on ICSD-3 criteria. 2. >=18 and = 25 kg/m2 Matched controls: 1. Biologically female. 2. Age- and BMI-match with patient. 3. White Caucasian descent.

Exclusion criteria

Exclusion criteria: Patients and matched controls: 1. Previous use of SXB. 2. Contraindications for SXB treatment. 3. Sleep-wake disorders other than narcolepsy type 1. 4. Renal, hepatic or endocrine disease. 5. Use of medication known to influence glucose and/or lipid metabolism or brown adipose tissue activity (e.g. β-adrenergic receptor blockers). 6. Participation in an intensive weight-loss program or vigorous exercise program during the year before the start of the study. 7. Pregnant during the study days (due to unreliable body composition measurements on the InBody machine)

Design outcomes

Primary

Measure	Time frame
The effect of 4 weeks SXB treatment on basal and cold-induced levels of circulating free fatty acids (FFA) in narcolepsy type 1 patients.	—

Secondary

Measure	Time frame
1. Baseline differences between narcolepsy type 1 patients and matched controls in: - Indirect markers for basal and cold-induced WAT lipolysis (measured by expression of genes and (phosphorylated) proteins involved in lipolysis and lipid content). - Serum markers for lipid metabolism metabolism (triglycerides (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), free fatty acids (FFA)). - Thermoneutral and cold-induced changes in free fatty acids (FFA). - Serum markers for glucose metabolism (glucose, insulin, cortisol). - Resting energy expenditure: measured by indirect calorimetry. - Skin temperature (as a proxy of BAT activity): measured by infrared thermography. - Fat/lean mass: measured by body composition analyzer (InBody720). - mRNA immune gene expression: measured by microfluidic qPCR analyses on whole blood. - Fecal microbiota composition: measured by 16S sequencing. 2. The effect of 4 weeks of SXB treatment in narcolepsy type 1 patients on all above-mentioned outcomes, excluding free fatty acids (FFA) which is already the primary outcome measure.	—

Measure

Time frame

1. Baseline differences between narcolepsy type 1 patients and matched controls in: - Indirect markers for basal and cold-induced WAT lipolysis (measured by expression of genes and (phosphorylated) proteins involved in lipolysis and lipid content). - Serum markers for lipid metabolism metabolism (triglycerides (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), free fatty acids (FFA)). - Thermoneutral and cold-induced changes in free fatty acids (FFA). - Serum markers for glucose metabolism (glucose, insulin, cortisol). - Resting energy expenditure: measured by indirect calorimetry. - Skin temperature (as a proxy of BAT activity): measured by infrared thermography. - Fat/lean mass: measured by body composition analyzer (InBody720). - mRNA immune gene expression: measured by microfluidic qPCR analyses on whole blood. - Fecal microbiota composition: measured by 16S sequencing. 2. The effect of 4 weeks of SXB treatment in narcolepsy type 1 patients on all above-mentioned outcomes, excluding free fatty acids (FFA) which is already the primary outcome measure.

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Countries

Netherlands

Outcome results