Long-term Treatment With the Ketogenic Diet in Epilepsy

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04646850

Enrollment

Registered

2020-11-30

Start date

2018-08-06

Completion date

2025-12-31

Last updated

2022-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, GLUT1DS1, PDH Deficiency

Keywords

Ketogenic dieting

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).

Interventions

OTHERColor 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).

Study design

Observational model

CASE_CONTROL

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026