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| Name | Class |
|---|---|
| IRCCS National Neurological Institute "C. Mondino" Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational group | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of ketogenic diet impact on ketonemia | Other | Ketonemia and glycemia levels monitoring during different phases of menstrual cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| To measure serum ketone bodies level through different phases of menstrual cycle | With regular home standardized measurements of capillary ketonemia | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pavia | Recruiting | Pavia | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37575326 | Derived | Pasca L, Ferraris C, Guglielmetti M, Varesio C, Totaro M, Trentani C, Marazzi C, Brambilla I, Ballante E, Armeno M, Valenzuela GR, Caraballo RH, Veggiotti P, Tagliabue A, De Giorgis V. Ketonemia variability through menstrual cycle in patients undergoing classic ketogenic diet. Front Nutr. 2023 Jul 27;10:1188055. doi: 10.3389/fnut.2023.1188055. eCollection 2023. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D000069279 | Drug Resistant Epilepsy |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000138 | Acidosis |
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| D000137 |
| Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |