neuro-endocriene/hypofyse aandoeningen acromegaly giantism
Conditions
Interventions
A eucaloric ketogenic diet (30-40 g carbohydrate per day) for 3 months,
followed by a less strict ketogenic diet (50-60 g carbohydrate per day) for
another 3 months. The control group will receive a
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in IGF-1 (expressed as times the upper limit of the normal range (xULN)) between control and intervention group during 6 months of dieting (continuous). | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life (AcroQol), diet adherence, change in body weight, body composition, resting energy expenditure, handgrip strength and plasma parameters. | — |
Countries
Netherlands
Outcome results
None listed