KETOgenic diet therapy in patients with HEPatocellular adenoma

Recruiting

Conditions: Hepatocellular adenoma. Benign Livertumor
10019813

Registration Number: NL-OMON49811

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 55

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

- Current pregnancy or breastfeeding
- Diabetes Mellitus type 1 or 2
- Insufficient understanding of the Dutch language
- Participation in another clinical study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our main study endpoint is the difference in tumour regression. The size<br /><br>(largest diameter in cm) of the largest hepatocellular adenoma found on MRI<br /><br>will be measured at T0 = time of inclusion and at T4= 6 months after start of<br /><br>the intervention. Mean regression will be calculated after which it will be<br /><br>compared to the regression in tumour size of our (earlier acquired) cohort and<br /><br>the subsequent internally validated model. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Feasibility / Adherence to the ketogenic diet<br /><br>- Change in plasma parameters: fasting glucose, fasting insulin, HbA1c, total<br /><br>cholesterol, HDL-cholesterol, LDL- cholesterol, free fatty acids, triglycerides<br /><br>levels, branched amino acids,<br /><br>- Quality of life<br /><br>- Change in body weight (kg)<br /><br>- Change in body composition (fat mass / fat free mass)<br /><br>- Resting Energy Expenditure </p><br>