Obese PatientsNCT07396896
KETO-TUMOR: a Study on Brain Tumors and Central Obesity
A study testing Dietary intervention in people with Obese Patients and Hypothalamic Neoplasms, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
Trial summary
Hypothalamic-chiasmatic tumours account for 5-10% of CNS tumours in children and can compromise hypothalamic function, causing alterations in energy balance and weight gain. In inoperable cases, chemotherapy and radiotherapy are used; the latter, although the gold standard, is associated with significant… Read more about this study
- Who is it for?
- Ages 7 to 30 years
- Conditions the study is for
- Obese Patients, Hypothalamic Neoplasms
- What is being tested?
- Dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 8 May 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of hypothalamic-chiasmatic tumour according to the WHO 2021 classification
- Diagnosis of hypothalamic obesity: after 5 years of age, BMI >97th percentile in the WHO 2007 curves
- Males and females aged between 7 and 30 years
- Performance status: Lansky score > 40 for patients aged < 18 years and Karnofsky score > 40 for patients aged between 18 and 30 years
- Signature of informed consent to participate in the study
- Signature of consent by the minor patient to participate in the study (7-13 years and 14-17 years).
Who cannot join
- 1. Deficiencies of:
- Primary carnitine
- Carnitine palmitoyltransferase 2 (CPT 2)
- Carnitine acylcarnitine translocase (CACT)
- Beta-oxidation
- Medium-chain acyl-CoA dehydrogenase (MCAD)
Show all 11Show fewer
- long-chain acyl-CoA dehydrogenase (LCAD)
- short-chain acyl-CoA dehydrogenase (SCAD)
- porphyria
- pyruvate carboxylase
- long-chain 3-hydroxyacyl-CoA dehydrogenase.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Meyer Children's Hospital IRCCS
Florence, Florence, 50139
Iacopo Sardi, 0555662631
About this study
Official title: Single-arm, Open-label, Single-center, Non-profit Interventional Clinical Trial on the Effects of the Ketogenic Diet in Patients With Brain Tumors and Central Obesity
Hypothalamic-chiasmatic tumours account for 5-10% of CNS tumours in children and can compromise hypothalamic function, causing alterations in energy balance and weight gain. In inoperable cases, chemotherapy and radiotherapy are used; the latter, although the gold standard, is associated with significant neurocognitive and endocrine-metabolic side effects, proportional to the hypothalamic damage.
The ketogenic diet, used for decades in the treatment of drug-resistant childhood epilepsy, induces the use of ketone bodies as a source of energy for the brain and is effective in controlling seizures. Among the different variants, the modified Atkins diet was chosen in this study to promote better patient adherence.
This study aims to evaluate the effectiveness of the ketogenic diet (KD) in treating central obesity secondary to hypothalamic-chiasmatic tumours (gliomas, craniopharyngiomas, germ cell tumours, etc.), which often lead to excessive weight gain. This is refractory to drug therapy and lifestyle changes, such as low-calorie diets and exercise.
- Conditions
- Obese Patients, Hypothalamic Neoplasms
- Being tested
- Dietary intervention
- Medical subject headings
- Hypothalamic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionBehavioural
Atkins Modified Diet (MAD)
| Study group | Role | What they receive |
|---|---|---|
| Keto-tumor | Experimental | Not described Receives: Behavioral: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who experience weight loss of at least 5% over 24 months
Measured: From enrollment to the end of the follow up period at 24 months
Secondary outcomes (5)
Percentage of patients showing weight reduction, improvement in lipid and carbohydrate parameters
Measured: From enrollment to the end of the follow up period at 24 months
Percentage of patients with ketosis
Measured: From enrollement to the end of the follow up period at 24 months
Percentage of patients with serious adverse events
Measured: From enrollement to the end of the follow up period at 24 months
Adherence rate to the proposed dietary intervention, considering the number of patients who discontinue the diet and those who continue it
Measured: From enrollment to the end of the follow up at 24 months
Percentage of patients showing reduction of lean body mass in 24 months
Measured: From enrollment to the end of the follow up period at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start8 May 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese PatientsStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iacopo Sardi, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396896
- Sponsor's protocol ID
- KETO-TUMOR
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Open-label, Single-center, Non-profit Interventional Clinical Trial on the Effects of the Ketogenic Diet in Patients With Brain Tumors and Central Obesity
- ClinicalTrials.gov ID
- NCT07396896
- Acronym / sponsor ID
- KETO-TUMOR
- Conditions
- Obese Patients, Hypothalamic Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 9 Feb 2026 (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.
Hypothalamic-chiasmatic tumours account for 5-10% of CNS tumours in children and can compromise hypothalamic function, causing alterations in energy balance and weight gain. In inoperable cases, chemotherapy and radiotherapy are used; the latter, although the gold standard, is associated with significant neurocognitive and endocrine-metabolic side effects, proportional to the hypothalamic damage.
The ketogenic diet, used for decades in the treatment of drug-resistant childhood epilepsy, induces the use of ketone bodies as a source of energy for the brain and is effective in controlling seizures. Among the different variants, the modified Atkins diet was chosen in this study to promote better patient adherence.
This study aims to evaluate the effectiveness of the ketogenic diet (KD) in treating central obesity secondary to hypothalamic-chiasmatic tumours (gliomas, craniopharyngiomas, germ cell tumours, etc.), which often lead to excessive weight gain. This is refractory to drug therapy and lifestyle changes, such as low-calorie diets and exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Keto-tumor | Experimental | Behavioral: Dietary intervention |
Who may qualify
- Ages
- 7 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Diagnosis of hypothalamic-chiasmatic tumour according to the WHO 2021 classification
- Diagnosis of hypothalamic obesity: after 5 years of age, BMI >97th percentile in the WHO 2007 curves
- Males and females aged between 7 and 30 years
- Performance status: Lansky score > 40 for patients aged < 18 years and Karnofsky score > 40 for patients aged between 18 and 30 years
- Signature of informed consent to participate in the study
Key exclusion criteria (11 listed)
- Primary carnitine
- Carnitine palmitoyltransferase 2 (CPT 2)
- Carnitine acylcarnitine translocase (CACT)
- Beta-oxidation
- Medium-chain acyl-CoA dehydrogenase (MCAD)
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 |
|---|---|---|
| Dietary interventionAtkins Modified Diet (MAD) | Behavioural | Keto-tumor |
Primary outcome
Percentage of patients who experience weight loss of at least 5% over 24 months
Time frame: From enrollment to the end of the follow up period at 24 months
5 secondary outcomes
Percentage of patients showing weight reduction, improvement in lipid and carbohydrate parameters
Time frame: From enrollment to the end of the follow up period at 24 months
Percentage of patients with ketosis
Time frame: From enrollement to the end of the follow up period at 24 months
Percentage of patients with serious adverse events
Time frame: From enrollement to the end of the follow up period at 24 months
Adherence rate to the proposed dietary intervention, considering the number of patients who discontinue the diet and those who continue it
Time frame: From enrollment to the end of the follow up at 24 months
Percentage of patients showing reduction of lean body mass in 24 months
Time frame: From enrollment to the end of the follow up period at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Obese Patients and Hypothalamic Neoplasms, run by Meyer Children's Hospital IRCCS 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iacopo Sardi (0555662631, iacopo.sardi@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who experience weight loss of at least 5% over 24 months (time frame: From enrollment to the end of the follow up period at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2026.