Drug Resistant Epilepsy, Epilepsy, GLUT1DS1, Ketogenic Dieting, Menstrual Epilepsy
Conditions
Keywords
ketogenic diet, ketonemia, menstrual cycle
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.
Interventions
OTHEREvaluation of ketogenic diet impact on ketonemia
Ketonemia and glycemia levels monitoring during different phases of menstrual cycles
Sponsors
IRCCS ISTITUTO NEUROLOGICO CASIMIRO MONDINO
University of Pavia
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure serum ketone bodies level through different phases of menstrual cycle | 3 months | With regular home standardized measurements of capillary ketonemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed