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临床试验/NCT06268353
NCT06268353招募中不适用

Is the Plasma Concentration of CAPGDF15 Increased in Pregnancy? A Pilot Study

University of Copenhagen4 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2024年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
6
试验地点
4
主要终点
CAPGDF15 levels in plasma

研究概览

简要总结

Background and Purpose During pregnancy, the hormone GDF15 rises between 100-200 times higher than before pregnancy. The significance of this dramatic increase is not clarified, but it has been shown that pregnant women with insufficient increase in GDF15 have a higher risk of spontaneous abortion. CAPGDF15 is a small peptide consisting of 12 amino acids recently found in plasma in both mice and humans, and this peptide is part of the prohormone from which GDF15 is synthesized. Therefore, the assumption is that CAPGDF15 is secreted simultaneously with GDF15. The significance of CAPGDF15 in the organism is completely unknown, except that injection into mice reduces food intake. Therefore, the investigators are interested in investigating whether there is a similar dramatic upregulation of CAPGDF15 as with GDF15 itself. The investigators will not set up a large-scale study without having some prior knowledge of whether this is indeed the case. Therefore, the investigators will conduct a pilot study on 3 pregnant women and 3 control women to examine whether there is any reason to proceed with an actual scientific experiment. Since the increase in GDF15 itself is very large at least100 fold, a pilot study involving only 3 pregnant women and 3 non-pregnant women will be sufficient to gain an impression of whether there is also a significant increase in CAPGDF15. The data will be used to assess whether an actual research project is worth establishing.

Purpose:

The purpose of conducting this pilot study is to investigate whether there is an upregulation of CAPGDF15 similar to that of the hormone GDF15 during pregnancy. By conducting a pilot study on 3 pregnant women and 3 control women, the investigators will see if this is actually the case before setting up an actual scientific experiment.

详细描述

Experimental Protocol

A total of 6 healthy and fit women will be included in the experiment, 3 pregnant and 3 non-pregnant fertile women matched for age and weight.

Recruitment of Subjects Subjects and matched control subjects will be recruited via Flyers (appendix) posted at the University of Copenhagen.

Inclusion Criteria:

  • Healthy and fit pregnant women in the 3rd trimester.
  • Healthy control subjects will be matched based on age and weight and must not be taking medication.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy and fit pregnant women in the 3rd trimester.
  • Healthy control subjects will be matched based on age and weight and must not be taking medication.

排除标准

  • Ongoing illness and/or medication intake

结局指标

主要结局

CAPGDF15 levels in plasma

时间窗: 1 year

single sample

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

Erik Richter

Professor MD DMSci

University of Copenhagen

研究点 (4)

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