An observational study in Epilepsy, Drug Resistant Epilepsy and GLUT1DS1, sponsored by University of Pavia. Recruiting at 1 site in Italy. Open to female participants aged 12 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by University of Pavia · Observational
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.
257 studies on the registry are indexed under Drug Resistant Epilepsy; 108 are open to participants now.
This study's planned enrollment of 15 is below the median of 88 across 44 observational studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →University of Pavia is the lead sponsor of 144 studies on the registry; 39 are open to participants now.
Compared within Drug Resistant Epilepsy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Epilepsy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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Exclusion Criteria:
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.
Other: Evaluation of ketogenic diet impact on ketonemia
Ketonemia and glycemia levels monitoring during different phases of menstrual cycles
To measure serum ketone bodies level through different phases of menstrual cycle
With regular home standardized measurements of capillary ketonemia
Time frame: 3 months
Evaluation of the efficacy of an individualized intermittent adjustment of the dietary regimen
Evaluation of ketonemia levels and clinical outcome once the therapeutic intervention is implemented
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2020 (actual). Primary completion is estimated for Sep 2023, 38 months after the start.
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