Ketonemia Through Menstrual Cycle

NCT ID: NCT05234411

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2023-12-31

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.

Conditions

Epilepsy; Drug Resistant Epilepsy; GLUT1DS1; Ketogenic Dieting; Menstrual Epilepsy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Evaluation of ketogenic diet impact on ketonemia

Intervention Type: OTHER

Ketonemia and glycemia levels monitoring during different phases of menstrual cycles

Interventions

Evaluation of ketogenic diet impact on ketonemia

Ketonemia and glycemia levels monitoring during different phases of menstrual cycles

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS ISTITUTO NEUROLOGICO CASIMIRO MONDINO

UNKNOWN

Sponsor Role: collaborator

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Cinzia Ferraris

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pavia

Pavia, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Cinzia Ferraris, PhD

Role: primary

cinzia.ferraris@gmail.com

+39 0382987868

References

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.

Reference Type: DERIVED

PMID: 37575326 (View on PubMed)

Other Identifiers

2021-KETOMENS

Identifier Type: -

Identifier Source: org_study_id