Long-term Treatment With the Ketogenic Diet in Epilepsy

Epilepsy Clinical Trial

Official title:

Long-term Treatment With the Ketogenic Diet in Epilepsy and Epilepsy-related Rare Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04646850
• Other study ID #: 18-14061
• Status: Active, not recruiting
• Start date: August 6, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• GLUT1DS1
• PDH Deficiency
• Pyruvate Dehydrogenase Complex Deficiency Disease

Intervention

Other:
• Color duplex ultrasound of the carotid arteries
Examinations carried out according to the American Society of Echocardiography guidelines 25 using a Vivid 7 US instrumentation with a linear M12L probe (14 MHZ; General Electric).

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular risk after long-term treatment with the ketogenic diet	Color duplex ultrasound	2018-2022