RecruitingNot ApplicableNCT06949891

KETOgenic Diet Therapy in Patients With ACROmegaly

Ketogenic Diet Therapy in Patients With Acromegaly


Sponsor

Erasmus Medical Center

Enrollment

60 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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 insulin like growth factor 1 (IGF-1), are disproportionate growth of body parts, fluid retention, snoring and excessive perspiration. The various metabolic changes that occur due to acromegaly increase the risk for insulin resistance, diabetes mellitus, arterial hypertension, sleep apnoea and thus an increased risk of cardiovascular disease if left untreated. The result is signs and symptoms, increased mortality, morbidity, and greatly reduced quality of life (QoL). Normalisation of GH and IGF-1 gives a normalisation of mortality, however morbidity and QoL do not (completely) normalise. After surgery, a somatostatin analogue is the primary medical treatment, however, normalisation occurs in only 40% of patients. Recently, in a proof-of-principle study, the researchers showed that a 2-week ketogenic diet (low in carbohydrates) in patients with somatostatin analogues could significantly reduce IGF-1 values. Patients felt better and sometimes even needed less somatostatin analogues. This proof of concept led to the new hypothesis that acromegaly patients with somatostatin analogues should possibly be treated with a eucaloric low-carbohydrate ketogenic diet for a longer period of time to improve their biochemistry, symptoms and QoL. Additionally, this diet can make a significant contribution in the treatment of insulin resistance and glucose intolerance that often occur in this patient group.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a ketogenic diet (a very low-carbohydrate, high-fat eating plan) can help lower elevated growth hormone or IGF-1 levels in patients with acromegaly — a hormonal condition caused by a pituitary tumor that produces too much growth hormone. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with acromegaly caused by a pituitary tumor - Your IGF-1 levels remain above 80% of the upper normal range despite being on a stable medication dose for at least 4 months - You are willing to follow the ketogenic diet during the study **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are taking a medication called pegvisomant - You have had pituitary surgery or radiation therapy within the past 6 months or plan to have it during the study - You have a history of epilepsy - Your HbA1c (blood sugar measure) is above 6.5% - You take diabetes medications other than Metformin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTKetogenic diet

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.

DIETARY_SUPPLEMENTMediterranean diet

The control group will receive a eucaloric diet according to the national healthy food guidelines/Mediterranean diet.


Locations(1)

Erasmus Medical Center

Rotterdam, Netherlands

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NCT06949891


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