Ketogenic (modified Atkins) diet for hypothalamic tumor–related central obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, single-center protocol enrolls patients aged 7–30 who have hypothalamic-chiasmatic tumors and severe hypothalamic obesity that is refractory to medical therapy. Participants will follow a modified Atkins ketogenic diet with regular clinical monitoring, metabolic laboratory testing, and safety checks, and individuals with inherited fatty-acid oxidation or related metabolic enzyme deficiencies are excluded. The research is conducted at Meyer Children's Hospital IRCCS in Florence and requires informed consent from patients and guardians for minors. Primary outcomes will focus on changes in weight/BMI and metabolic/endocrine markers, along with measures of tolerability and adherence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of hypothalamic-chiasmatic tumour according to the WHO 2021 classification
2. Diagnosis of hypothalamic obesity: after 5 years of age, BMI \>97th percentile in the WHO 2007 curves
3. Males and females aged between 7 and 30 years
4. Performance status: Lansky score \> 40 for patients aged \< 18 years and Karnofsky score \> 40 for patients aged between 18 and 30 years
5. Signature of informed consent to participate in the study
6. Signature of consent by the minor patient to participate in the study (7-13 years and 14-17 years).

Exclusion Criteria:

1\. Deficiencies of:

* Primary carnitine
* Carnitine palmitoyltransferase 2 (CPT 2)
* Carnitine acylcarnitine translocase (CACT)
* Beta-oxidation
* Medium-chain acyl-CoA dehydrogenase (MCAD)
* long-chain acyl-CoA dehydrogenase (LCAD)
* short-chain acyl-CoA dehydrogenase (SCAD)
* porphyria
* pyruvate carboxylase
* long-chain 3-hydroxyacyl-CoA dehydrogenase.

Where it's running

• Meyer Children's Hospital IRCCS
  Florence, Florence, Italy Recruiting

Study contacts

• Study coordinator: Iacopo Sardi
• Email: iacopo.sardi@meyer.it
• Phone: 0555662631

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.