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KETOgenic Diet Therapy in Patients With ACROmegaly

RecruitingNAAges 18 Years - anyAllErasmus Medical Center
NCT06949891 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 onl

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📋 Eligibility rules (as published)
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
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What it tests

  • Ketogenic diet
  • Mediterranean diet
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Where

1 site
Erasmus Medical Center
Rotterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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