NCT05234411

Ketonemia Through Menstrual Cycle

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: University of Pavia · Academic / Other
• Sex: Female
• Age: 12 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Epilepsy
• Drug Resistant Epilepsy
• GLUT1DS1
• Ketogenic Dieting
• Menstrual Epilepsy

Interventions

Type	Name	Description
OTHER	Evaluation of ketogenic diet impact on ketonemia	Ketonemia and glycemia levels monitoring during different phases of menstrual cycles

Timeline

• Start date: 2020-07-01
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2022-02-10
• Last updated: 2023-05-11

Locations

1 site across 1 country: Italy