Long-term Treatment With the Ketogenic Diet in Epilepsy

Active, not recruiting

• Conditions: GLUT1DS1; Epilepsy; PDH Deficiency

• Registration Number: NCT04646850
• Lead Sponsor: Oslo University Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-06
• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2020-11-26
• Study First Posted: 2020-11-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-21
• Primary Completion: 2022-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular risk after long-term treatment with the ketogenic diet	2018-2022	Color duplex ultrasound

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway