Ketonemia Through Menstrual Cycle
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To measure serum ketone bodies level through different phases of menstrual cycle
研究概览
简要总结
Ketogenic dietary therapies (KDTs) are well-established, safe, non-pharmacologic treatments used for children and adults with drug-resistant epilepsy and other neurological disorders. Ketone bodies levels undergo a significant inter-individual and intra-individual variability and can be affected by several factors. This evidence suggests the need for personalized monitoring for diet optimization, especially at the beginning of the treatment but during whole follow-up. Possible variations in glycemia and ketone bodies' blood level according to different phases of menstrual cycle have not been systematically assessed yet, but this time window deserves special attention because of hormonal and metabolic related changes. We present the methodological protocol for a longitudinal, multicentric study aimed at searching for subtle changes in ketone bodies blood level during menstrual cycle in epileptic female patients undergoing a stable ketogenic diet. The study will be divided into two phases. The first one will be purely observational, aiming at the assessment of ketonemia during menstrual cycle. Whether this finding will be confirmed, a second phase of ketogenic diet therapy adjustment will be scheduled.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 35 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with drug resistant epilepsy or GLUT1DS undergoing KD from at least 3 months before inclusion to the study
- •Patients who had menarche at least 3 months before inclusion to the study
- •Absence of recognized endocrinologic problems/ disease
排除标准
- •Patients who experienced secondary amenorrhea
- •Patients who have irregular menstrual cycle
- •Pregnant patients
结局指标
主要结局
To measure serum ketone bodies level through different phases of menstrual cycle
时间窗: 3 months
With regular home standardized measurements of capillary ketonemia
次要结局
- Evaluation of the efficacy of an individualized intermittent adjustment of the dietary regimen(3 months)
研究者
Cinzia Ferraris
Researcher
University of Pavia
