NL-OMON53303招募中不适用
Ketogenic diet therapy in patients with acromegaly - KetoAcro trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Main study population
- •Patients (>=18 years) with active acromegaly will be recruited from the
- •Pituitary Centre Rotterdam outpatient clinic of the Erasmus MC and via the
- •*Nederlandse Hypofyse Stichting*, the national patient association. Our own
- •cohort follows over fifty patients with acromegaly on somatostatin analogue
- •monotherapy, and the National Patient Association approximately has 400 active
- •members with acromegaly, making it likely that we will be able to reach the
- •planned number of patients.
- •Sub study population
- •Patients with uncontrolled acromegaly with pegvismant treatment, will start
- •with ketogenic diet for three months, as a pilot study, with the same
- •recruitement strategy and the same in- and exclusion criteria only without
- •exclusion of pegvisomant.
排除标准
- •- Pregnancy or breastfeeding
- •- Pegvisomant treatment (not for subpopulation)
- •- Has undergone pituitary surgery or radiotherapy within 6 months prior to
- •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 systemic corticosteroids within 60 days prior to screening
研究者
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