Hepatocellular adenoma. Benign Livertumor
Conditions
Interventions
Diet:
Month 1-3: Low carbohydrate, ketogenic diet containing approximately 1500 kcal,
35grams of carbohydrate and 0.8 g/kg of protein /day
Month 4-6: Moderate carbohydrate, ketogenic diet containing
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Main study population: Female subjects with a hepatocellular adenoma, who are advised to enter an initial surveillance period of 6 months after diagnosis, after reviewing their case by the multidisciplinary team of experts, including a hepatobiliary surgeon, a hepatologist and a liver radiologist. Study subpopulation: Female subjects with a hepatocellular adenoma, who after the initial surveillance period of 6 months including the regular treatment advice of losing weight and cessation of use of oral contraceptives, did not or only minimally (5mm) experience a reduction of the size of the HCA. Standard treatment for this subgroup after the 6 months of initial surveillance would consist of an additional surveillance period of 6 months, after which another MRI would be performed to assess the change in size of HCA. Inclusion Criteria: - Age 18-50 years - BMI > 25 kg/m2 - Provide written consent
Exclusion criteria
Exclusion criteria: - Current pregnancy or breastfeeding - Diabetes Mellitus type 1 or 2 - Insufficient understanding of the Dutch language - Participation in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our main study endpoint is the difference in tumour regression. The size (largest diameter in cm) of the largest hepatocellular adenoma found on MRI will be measured at T0 = time of inclusion and at T4= 6 months after start of the intervention. Mean regression will be calculated after which it will be compared to the regression in tumour size of our (earlier acquired) cohort and the subsequent internally validated model. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Feasibility / Adherence to the ketogenic diet - Change in plasma parameters: fasting glucose, fasting insulin, HbA1c, total cholesterol, HDL-cholesterol, LDL- cholesterol, free fatty acids, triglycerides levels, branched amino acids, - Quality of life - Change in body weight (kg) - Change in body composition (fat mass / fat free mass) - Resting Energy Expenditure | — |
Countries
Netherlands
Outcome results
None listed