Long-term Treatment With the Ketogenic Diet in Epilepsy (NCT04646850) | Clinical Trial Compass
UnknownNot Applicable
Long-term Treatment With the Ketogenic Diet in Epilepsy
Norway30 participantsStarted 2018-08-06
Plain-language 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).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cardiovascular risk after long-term treatment with the ketogenic diet