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临床试验/NL-OMON49811
NL-OMON49811招募中不适用

KETOgenic diet therapy in patients with HEPatocellular adenoma - Ketohep(py)-Study

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 55 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
55

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:
  • Female subjects with a hepatocellular adenoma, who are advised to enter an
  • initial surveillance period of 6 months after diagnosis, after reviewing their
  • case by the multidisciplinary team of experts, including a hepatobiliary
  • surgeon, a hepatologist and a liver radiologist.
  • Study subpopulation:
  • Female subjects with a hepatocellular adenoma, who after the initial
  • surveillance period of 6 months including the regular treatment advice of
  • losing weight and cessation of use of oral contraceptives, did not or only
  • minimally (5mm) experience a reduction of the size of the HCA. Standard
  • treatment for this subgroup after the 6 months of initial surveillance would
  • consist of an additional surveillance period of 6 months, after which another
  • MRI would be performed to assess the change in size of HCA.
  • Inclusion Criteria:
  • - Age 18-50 years
  • - BMI > 25 kg/m2
  • - Provide written consent

排除标准

  • - Current pregnancy or breastfeeding
  • - Diabetes Mellitus type 1 or 2
  • - Insufficient understanding of the Dutch language
  • - Participation in another clinical study

研究者

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