Ketogenic diet therapy for patients with acromegaly
Ketogenic Diet Therapy in Patients With Acromegaly
This study tests whether a ketogenic diet can help people with acromegaly lower their growth hormone levels and improve their quality of life compared to a Mediterranean diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT06949891 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a ketogenic diet compared to a Mediterranean diet in patients diagnosed with acromegaly due to a pituitary adenoma. Acromegaly is characterized by excessive growth hormone production, leading to various health complications. The trial aims to assess whether dietary interventions can help normalize growth hormone and IGF-1 levels, potentially improving patient outcomes. Participants will be monitored for changes in metabolic parameters and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with diagnosed acromegaly and elevated IGF-I levels due to a pituitary tumor.
Not a fit: Patients who are pregnant, breastfeeding, or have undergone recent pituitary surgery or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel dietary management strategy to improve health outcomes for patients with acromegaly.
How similar studies have performed: While dietary interventions in acromegaly are less commonly explored, preliminary studies suggest potential benefits, indicating this approach may be novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rotterdam
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Kirsten A. Berk, Dr.
- Email: k.berk@erasmusmc.nl
- Phone: +31 0107033055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.