Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06268353 |
| Other study ID # |
109324-1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2024 |
| Est. completion date |
March 15, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
University of Copenhagen |
| Contact |
Erik A Richter, MD |
| Phone |
+4528751626 |
| Email |
erichter[@]nexs.ku.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
Exclusion Criteria:
* Ongoing illness and/or medication intake
Recruitment Procedure and Oral Participant Information The initial contact with a potential
participant will be used to address questions about the study. Subsequently, a pre-screening
will be conducted over the phone, where inclusion and exclusion criteria will be assessed.
Individuals who do not meet the inclusion and exclusion criteria or who do not wish to
participate after the initial pre-screening will not be further inconvenienced.
Experimental Day On the 1st and only visit to the experimental site The participant's
pregnancy status, gestational week, and age are noted. Weight A routine venous blood sample
is taken from one arm vein.
Maximum 1 hour
Outcome Parameters and Method There is no intervention in this experiment. A routine blood
sample of 3 ml will be taken from 3 pregnant women and 3 matched non-pregnant control women.
Statistical Considerations:
No formal power calculation has been made, but since the increase in GDF15 itself is
significant, 3 pregnant women and 3 non-pregnant women are expected to be sufficient to gain
an impression of whether there is also a significant increase in CAPGDF15.
Ethical Considerations:
The project primarily has a basic research perspective. Therefore, there will be no benefits
for the participants in participating in the project. The expected basic scientific
contribution, in our opinion, will outweigh the discomfort experienced by the participants.
Informed consent will be obtained from all participants in accordance with the guidelines of
the ethics committee. The experiment, which consists of collecting a single blood sample,
will not entail any significant health risks for the participants. If significant information
about the participant's health status emerges during the trial period, the participant will
be informed, provided consent has been given during the information session. The participant
can at any time obtain information about the data - and after the end of the trial
information about the result. The trial has been approved by the Ethics Committee RegionH
under journal number: Hxxxxxxxx.
Side Effects, Risks, and Disadvantages:
Simple measurements of the body, such as weight and height, are performed using appropriate
measuring equipment. These measurements are not expected to entail any risk or discomfort.
Blood samples will be taken by the responsible physician. Mild pain may occur at the
injection site. In addition, there is a small risk of swelling and tenderness and a small
bruise at the injection site, which will disappear after a few days.
