Long-term Treatment With the Ketogenic Diet in Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-06

Study Completion Date

2025-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Epilepsy GLUT1DS1 PDH Deficiency

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No