跳至主要内容
临床试验/NCT06949891
NCT06949891招募中不适用

Ketogenic Diet Therapy in Patients With Acromegaly

Erasmus Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
IGF-1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

IGF-1

时间窗: At baseline, 3 months and 6 months.

Difference in IGF-1 (expressed as times the upper limit of the normal range (xULN) in nmol/L) between control and intervention group.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kirsten A Berk, RD, PhD

Senior Researcher, Assistant Professor, Department Internal Medicine - Dietetics (+31)107040567 k.berk@erasmusmc.nl Dr. Molewaterplein 40, 3015 GD Rotterdam Postbus 2040, 3000

Erasmus Medical Center

研究点 (2)

Loading locations...

相似试验