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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of patients who experience weight loss of at least 5% over 24 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Keto-tumor
干预措施: Dietary intervention (Behavioral)
结局指标
主要结局
Percentage of patients who experience weight loss of at least 5% over 24 months
时间窗: From enrollment to the end of the follow up period at 24 months
次要结局
- Percentage of patients showing weight reduction, improvement in lipid and carbohydrate parameters(From enrollment to the end of the follow up period at 24 months)
- Percentage of patients with ketosis(From enrollement to the end of the follow up period at 24 months)
- Percentage of patients with serious adverse events(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(From enrollment to the end of the follow up at 24 months)
- Percentage of patients showing reduction of lean body mass in 24 months(From enrollment to the end of the follow up period at 24 months)
研究者
Iacopo Sardi
MD
Meyer Children's Hospital IRCCS