Ketonemia Through Menstrual Cycle

Epilepsy Clinical Trial

— KETOMENS  

Official title:

Ketonemia Through Menstrual Cycle

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05234411
• Other study ID #: 2021-KETOMENS
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• GLUT1DS1
• Ketogenic Dieting
• Ketosis

Intervention

Other:
• Evaluation of ketogenic diet impact on ketonemia
Ketonemia and glycemia levels monitoring during different phases of menstrual cycles

Locations

Country	Name	City	State
Italy	University of Pavia	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
University of Pavia	IRCCS ISTITUTO NEUROLOGICO CASIMIRO MONDINO

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure serum ketone bodies level through different phases of menstrual cycle	With regular home standardized measurements of capillary ketonemia	3 months
Secondary	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