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临床试验/NCT05234411
NCT05234411招募中不适用

Ketonemia Through Menstrual Cycle

University of Pavia1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年7月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cinzia Ferraris

Researcher

University of Pavia

研究点 (1)

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