KETOgenic Diet Therapy in Patients With ACROmegaly

Официальное название

Ketogenic Diet Therapy in Patients With Acromegaly

Обзор

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.

Вмешательства

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

Первичные конечные точки

• IGF-1 [Срок оценки: At baseline, 3 months and 6 months.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Erasmus Medical Center — Rotterdam

Идентификаторы

NCT: NCT06949891 · NL8384107823

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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