Long-term Treatment With the Ketogenic Diet in Epilepsy

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Epilepsy; GLUT1DS1; PDH Deficiency
• Intervention / Treatment: Other: Color duplex ultrasound of the carotid arteries

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with the ketogenic diet (classical or modified) for epilepsy, GLUT1 deficiency or PDHD at The National Centre for Epilepsy - SSE for 5 years or longer.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular risk after long-term treatment with the ketogenic diet	Color duplex ultrasound	2018-2022

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Anette Ramm-Pettersen, MD PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2018
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Ketogenic dieting
• Additional Relevant MeSH Terms: Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Mental Retardation, X-Linked; Intellectual Disability; Heredodegenerative Disorders, Nervous System; Brain Diseases, Metabolic; Mitochondrial Diseases; Brain Diseases, Metabolic, Inborn; Pyruvate Metabolism, Inborn Errors; Epilepsy; Pyruvate Dehydrogenase Complex Deficiency Disease
• Other Study ID Numbers: 18-14061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No