Long-term Treatment With the Ketogenic Diet in Epilepsy

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: GLUT1DS1; Epilepsy; PDH Deficiency

Treatments: Other: Color duplex ultrasound of the carotid arteries

Study type: Observational

Funder types: Other

Identifiers

NCT04646850

18-14061

Details and patient eligibility

About

This study will provide a comprehensive assessment of long-term treatment with the ketogenic diet, a medical diet with high fat and low carbohydrate intake, focusing on safety and cardiovascular implications. We will assess patients with epilepsy or one of two rare metabolic diseases; glucose transporter type 1 deficiency syndrome (GLUT1 DS) or pyruvate dehydrogenase complex deficiency (PDHD).

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment with the ketogenic diet at the National Centre for Epilepsy (SSE) for 5 years or more
• Able to travel from The National Centre for Epilepsy - SSE (Sandvika) to Rikshospitalet (Gaustad) to perform procedures to investigate cardiovascular risk factors
• Willing to draw extra blood for research purposes
• Willing to sign informed consent and participate in the study in accordance with the study protocol
• Willing to sign informed consent for blood samples to be included in research biobank at the Department of Neurology, Oslo University Hospital

Exclusion criteria

• Non-compliance with the dietary treatment for 6 months or longer or more than once per month
• Not possible to communicate with parents in Norwegian or English without interpreter
• Patient not able to cooperate and lie still for about ten minutes during the carotid ultrasound examination
• Psychiatric/mental illness, alcohol or drug abuse or other factors making it impossible to pursue the study protocol