KETOgenic diet therapy in patients with HEPatocellular adenoma
Recruiting
- Conditions
- Hepatocellular Adenoma (HCA), an uncommon, solid, benign liver lesion. Typically, it is a solitary lesion found in young women within their reproductive years.
- Registration Number
- NL-OMON24681
- Lead Sponsor
- Investigator Initiated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 55
Inclusion Criteria
Age 18-50 years
-BMI > 25 kg/m2
-Provide written consent
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-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 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 T5= 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.
- Secondary Outcome Measures
Name Time Method Quality of Life, change in body weight, body composition, resting energy expenditure and plasma parameters.