Actively Recruiting
Ketogenic Diet Therapy in Patients With Acromegaly
Led by Erasmus Medical Center · Updated on 2025-04-29
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Acromegaly is a condition caused by a tumor in the pituitary gland that produces too much growth hormone, leading to symptoms like enlarged body parts, fluid retention, snoring, and excessive sweating. This condition increases the risk of insulin resistance, diabetes, high blood pressure, sleep apnea, and cardiovascular disease, which can reduce quality of life and increase mortality. Normalizing hormone levels improves survival but does not fully restore quality of life or reduce all symptoms. Surgery and somatostatin analogues are common treatments, but only about 40% of patients achieve hormone normalization with medication. This trial compares two diets for people with acromegaly who are on stable somatostatin analogue treatment: a ketogenic diet low in carbohydrates and a Mediterranean diet following national healthy food guidelines. Participants in the ketogenic diet group follow a strict low-carbohydrate diet (30-40 grams per day) for three months, then a less strict ketogenic diet (50-60 grams carbohydrate per day) for another three months. The control group follows a Mediterranean diet for six months. The study is randomized with single masking. Participants will have their insulin-like growth factor 1 (IGF-1) levels measured at the start of the study, after three months, and after six months to assess treatment effects. The study also monitors symptoms, metabolic changes, and quality of life. The total participation lasts six months, with continued evaluation of hormone levels and health during this period to understand how diet impacts acromegaly management alongside medication.
CONDITIONS
Brief Title
KETOgenic Diet Therapy in Patients With ACROmegaly
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 years or older
- Diagnosis of acromegaly based on elevated growth hormone and/or insulin-like growth factor 1 levels due to a pituitary tumor
- IGF-1 levels above 80% of the upper limit of normal while on stable medication for at least 4 months
- Written informed consent to participate
You will not qualify if you...
- Pregnancy or breastfeeding
- Treatment with pegvisomant
- Pituitary surgery or radiotherapy within 6 months before study entry
- Planned pituitary surgery or radiotherapy during the study
- History or presence of epilepsy
- Participation in another experimental drug or device trial within 30 days before screening
- Mental condition preventing understanding of the study
- Screening HbA1c above 6.5%
- Use of antidiabetic medication other than metformin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants follow either a ketogenic diet or a Mediterranean diet to manage acromegaly.
Visits at baseline, 3 months, and 6 months
Trial Site Locations
Total: 1 location
1
Erasmus Medical Center
Rotterdam, Netherlands, 3015 GE
Actively Recruiting
Research Team
K
Kirsten A. Berk, Dr.
E
Eline te Nijenhuis-Noort, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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