Ketonemia Through Menstrual Cycle

Recruiting

• Conditions: GLUT1DS1; Menstrual Epilepsy; Epilepsy; Drug Resistant Epilepsy; Ketogenic Dieting
• Interventions: Other: Evaluation of ketogenic diet impact on ketonemia

• Registration Number: NCT05234411
• Lead Sponsor: University of Pavia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• 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

Exclusion Criteria

• Patients who experienced secondary amenorrhea
• Patients who have irregular menstrual cycle
• Pregnant patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational group	Evaluation of ketogenic diet impact on ketonemia	Eligible participants will be female patients aged 13 years or older, with regular menstrual cycle, who have been undergoing a KDT for at least 3 months and thus previously diagnosed with Drug resistant epilepsy or GLUT1DS.

Primary Outcome Measures

Name	Time	Method
To measure serum ketone bodies level through different phases of menstrual cycle	3 months	With regular home standardized measurements of capillary ketonemia

Secondary Outcome Measures

Name	Time	Method
Evaluation of the efficacy of an individualized intermittent adjustment of the dietary regimen	3 months	Evaluation of ketonemia levels and clinical outcome once the therapeutic intervention is implemented

Trial Locations

Locations (1)

University of Pavia; 🇮🇹 Pavia, Italy