Long-term Treatment With the Ketogenic Diet in Epilepsy

NCT04646850 | Unknown

• 1 other identifier: 18-14061
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Epilepsy; GLUT1DS1; PDH Deficiency

Keywords

Ketogenic dieting

Outcome Measures

Primary Outcomes (1)

• Cardiovascular risk after long-term treatment with the ketogenic diet

  Color duplex ultrasound

  2018-2022

Interventions

Color duplex ultrasound of the carotid arteries OTHER

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Epilepsy; Pyruvate Dehydrogenase Complex Deficiency Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System; Metabolism, Inborn Errors; Pyruvate Metabolism, Inborn Errors; Carbohydrate Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Mitochondrial Diseases

Study Officials

• Anette Ramm-Pettersen, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Child Neurology

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: November 30, 2020
• Study Start: August 6, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

NO (1)