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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05234411
Other study ID # 2021-KETOMENS
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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