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Ketonemia Through Menstrual Cycle

NCT05234411 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2023-05-11

No results posted yet for this study

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

OTHER

Evaluation of ketogenic diet impact on ketonemia

Ketonemia and glycemia levels monitoring during different phases of menstrual cycles

Sponsors & Collaborators

  • IRCCS ISTITUTO NEUROLOGICO CASIMIRO MONDINO

    collaborator UNKNOWN

  • University of Pavia

    lead OTHER

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-09-30
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234411 on ClinicalTrials.gov