EpilepsyKETOMENSNCT05234411
Ketonemia Through Menstrual Cycle
An observational study of Epilepsy and Drug Resistant Epilepsy, run by University of Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 12 to 35 years, women only
- Conditions the study is for
- Epilepsy, Drug Resistant Epilepsy, GLUT1DS1
- What is being tested?
- Evaluation of ketogenic diet impact on ketonemia
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who experienced secondary amenorrhea
- Patients who have irregular menstrual cycle
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Pavia
Pavia, 27100
Cinzia Ferraris, PhD, +39 0382987868, cinzia.ferraris@gmail.com
Valentina De Giorgis, PhD
About this study
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.
- Being tested
- Evaluation of ketogenic diet impact on ketonemia
- Keywords
- ketogenic diet, ketonemia, menstrual cycle
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of ketogenic diet impact on ketonemiaOther
Ketonemia and glycemia levels monitoring during different phases of menstrual cycles
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Evaluation of ketogenic diet impact on ketonemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure serum ketone bodies level through different phases of menstrual cycle
With regular home standardized measurements of capillary ketonemia
Measured: 3 months
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Jul 2020
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Responsible party
- Principal investigator, Cinzia Ferraris, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234411
- Sponsor's protocol ID
- 2021-KETOMENS
- Acronym
- KETOMENS
- Status last verified
- May 2023
- First submitted
- 31 Jan 2022
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37575326
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketonemia Through Menstrual Cycle
- ClinicalTrials.gov ID
- NCT05234411
- Acronym / sponsor ID
- KETOMENS / 2021-KETOMENS
- Keywords
- ketogenic diet, ketonemia, menstrual cycle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: Evaluation of ketogenic diet impact on ketonemiaEligible 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. |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who experienced secondary amenorrhea
- Patients who have irregular menstrual cycle
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of ketogenic diet impact on ketonemiaKetonemia and glycemia levels monitoring during different phases of menstrual cycles | Other | Observational group |
Primary outcome
To measure serum ketone bodies level through different phases of menstrual cycle
Time frame: 3 months
With regular home standardized measurements of capillary ketonemia
1 secondary outcome
Evaluation of the efficacy of an individualized intermittent adjustment of the dietary regimen
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 37575326Pasca 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Drug Resistant Epilepsy, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure serum ketone bodies level through different phases of menstrual cycle (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05234411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.