NCT04646850进行中（未招募）不适用
Long-term Treatment With the Ketogenic Diet in Epilepsy and Epilepsy-related Rare Diseases
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年8月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cardiovascular risk after long-term treatment with the ketogenic diet
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cardiovascular risk after long-term treatment with the ketogenic diet
时间窗: 2018-2022
Color duplex ultrasound
次要结局
未报告次要终点
研究者
Anette Ramm-Pettersen
Head of Child Neurology
Oslo University Hospital
研究点 (1)
Loading locations...
相似试验
招募中
3 期
Ketogenic Diet for New-Onset Absence EpilepsyAbsence EpilepsyKetogenic DietingEpilepsy, AbsenceNCT04274179Johns Hopkins University40
已完成
不适用
Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain InjuryTraumatic Brain InjuryNCT04933448Gillette Children's Specialty Healthcare7
尚未招募
不适用
Effectiveness of Ketogenic Diet in MELAS SyndromeMELAS SyndromeKetogenic DietingNCT06013397Second Affiliated Hospital, School of Medicine, Zhejiang University100
已完成
不适用
Utilization of the Ketogenic Diet in Patient With Relapsing Remitting MSRelapsing Remitting Multiple SclerosisNCT03718247University of Virginia45
Unknown
2 期
Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep ApneaObstructive Sleep ApneaObesityDiabetesNCT02069197Mid-Atlantic Epilepsy and Sleep Center, LLC150