KETOgenic Diet Therapy in Patients With ACROmegaly

Launched by ERASMUS MEDICAL CENTER · Apr 25, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a ketogenic diet—a low-carbohydrate, high-fat diet—on patients with acromegaly, a condition caused by a tumor in the pituitary gland that leads to too much growth hormone in the body. The researchers want to find out if this diet can help lower levels of a hormone called IGF-1, which is linked to the symptoms of acromegaly, such as unusual growth, sleep problems, and increased risk of diabetes and heart disease. By following this diet for a longer period, they hope to improve patients' overall health, well-being, and quality of life.

To be eligible for this study, participants need to be at least 18 years old, diagnosed with acromegaly, and have specific hormone levels indicating they are still experiencing symptoms despite stable medication for at least four months. They should not be pregnant, have certain medical conditions, or be involved in other experimental treatments. Participants can expect to follow the ketogenic diet while continuing their current treatment and will be monitored for improvements in their health. This trial could offer new insights into dietary approaches for managing acromegaly and improving patients' lives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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