Status:
RECRUITING
KETOgenic Diet Therapy in Patients With ACROmegaly
Lead Sponsor:
Erasmus Medical Center
Conditions:
Acromegaly Due to Pituitary Adenoma
Ketogenic Diet
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Acromegaly is caused by a tumour located at the base of the brain in the pituitary gland that produces too much growth hormone (GH). Symptoms caused by the excess of GH, and consequently increased ins...
Eligibility Criteria
Inclusion
- Male or female, 18 years or older
- Diagnosis of acromegaly based on elevated GH and/or IGF-I levels due to a pituitary tumor
- IGF-I levels above 80% upper limit of the normal range (xULN)) on a stable medication dose for at least 4 months
- Written informed consent
Exclusion
- Pregnancy or breastfeeding
- Pegvisomant treatment
- Has undergone pituitary surgery or radiotherapy within 6 months prior to s 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 antidiabetic medication other than Metformin
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06949891
Start Date
June 1 2023
End Date
May 1 2028
Last Update
April 29 2025
Active Locations (1)
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1
Erasmus Medical Center
Rotterdam, Netherlands, 3015 GE