Ketogenic diet therapy in patients with acromegaly
- Conditions
- neuro-endocriene/hypofyse aandoeningenacromegalygiantism
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 70
Main study population
Patients (>=18 years) with active acromegaly will be recruited from the
Pituitary Centre Rotterdam outpatient clinic of the Erasmus MC and via the
*Nederlandse Hypofyse Stichting*, the national patient association. Our own
cohort follows over fifty patients with acromegaly on somatostatin analogue
monotherapy, and the National Patient Association approximately has 400 active
members with acromegaly, making it likely that we will be able to reach the
planned number of patients.
Sub study population
Patients with uncontrolled acromegaly with pegvismant treatment, will start
with ketogenic diet for three months, as a pilot study, with the same
recruitement strategy and the same in- and exclusion criteria only without
exclusion of pegvisomant.
- Pregnancy or breastfeeding
- Pegvisomant treatment (not for subpopulation)
- Has undergone pituitary surgery or radiotherapy within 6 months prior to
study entry;
- It is anticipated that the patient will receive pituitary surgery or
radiotherapy during the study;
- History or presence of epilepsy;
- Participation in a trail of an experimental drug or device within 30 days
prior to screening;
- Has a mental condition rendering the subject unable to understand the nature,
scope and possible consequences of the study
- Screening HbA1c > 6,5%;
- Use of systemic corticosteroids within 60 days prior to screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Difference in IGF-1 (expressed as times the upper limit of the normal range<br /><br>(xULN)) between control and intervention group during 6 months of dieting<br /><br>(continuous). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Quality of Life (AcroQol), diet adherence, change in body weight, body<br /><br>composition, resting energy expenditure, handgrip strength and plasma<br /><br>parameters.</p><br>