Ketonemia Through Menstrual Cycle (KETOMENS)

May 10, 2023 updated by: Cinzia Ferraris, University of Pavia
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • University of Pavia
        • Contact:
        • Principal Investigator:
          • Valentina De Giorgis, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Evaluation of ketogenic diet impact on ketonemia
Ketonemia and glycemia levels monitoring during different phases of menstrual cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure serum ketone bodies level through different phases of menstrual cycle
Time Frame: 3 months
With regular home standardized measurements of capillary ketonemia
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the efficacy of an individualized intermittent adjustment of the dietary regimen
Time Frame: 3 months
Evaluation of ketonemia levels and clinical outcome once the therapeutic intervention is implemented
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Collaborators

IRCCS ISTITUTO NEUROLOGICO CASIMIRO MONDINO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-KETOMENS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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