NCT05234411

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

3.2 years

First QC Date

January 31, 2022

Last Update Submit

May 10, 2023

Conditions

EpilepsyDrug Resistant EpilepsyGLUT1DS1Ketogenic DietingMenstrual Epilepsy

Keywords

ketogenic dietketonemiamenstrual cycle

Outcome Measures

Primary Outcomes (1)

  • To measure serum ketone bodies level through different phases of menstrual cycle

    With regular home standardized measurements of capillary ketonemia

    3 months

Secondary Outcomes (1)

  • Evaluation of the efficacy of an individualized intermittent adjustment of the dietary regimen

    3 months

Study Arms (1)

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

Interventions

Evaluation of ketogenic diet impact on ketonemiaOTHER

Ketonemia and glycemia levels monitoring during different phases of menstrual cycles

Observational group

Eligibility Criteria

Age12 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details* Patients who had menarche at least 3 months before inclusion to the study * Patients undergoing KDTs from at least 3 months
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Absence of recognized endocrinologic problems/ disease

You may not qualify if:

  • Patients who experienced secondary amenorrhea
  • Patients who have irregular menstrual cycle
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pavia

Pavia, 27100, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37575326DERIVED

MeSH Terms

Conditions

EpilepsyDrug Resistant EpilepsyKetosis

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 10, 2022

Study Start

July 1, 2020

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)