Pregnancy RelatedCAPNCT06268353
Is the Plasma Concentration of CAPGDF15 Increased in Pregnancy? A Pilot Study
A study testing blood sampling in people with Pregnancy Related, run by University of Copenhagen at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Mar 2024to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Ongoing illness and/or medication intake
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
August Krogh Building
Copenhagen, 2100
Christian Voldstedlund, MS, Voldstedlund@nexa.ku.dk
Erik A. Richter, 28751626, erichter@nexs.ku.dk
- Recruiting
University of Copenhagen, August Krogh Section for Molecular Physiology
Copenhagen, Østerbro, 2100
Erik A Richter, 28751626 ext. 0045, erichter@nexs.ku.dk
Christian T Voldstedlund, 61671714 ext. 0045, Voldstedlund@nexs.ku.dk
About this study
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.
Read the detailed 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.
- Conditions
- Pregnancy Related
- Being tested
- blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
Measure CAPGDF15 in plasma of 3 pregnant and 3 non-pregnant women
| Study group | Role | What they receive |
|---|---|---|
| pregnancy | Experimental | Non-pregnant and pregnant women are compared Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPGDF15 levels in plasma
single sample
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Mar 2024
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Non-pregnant controls and pregnant women
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Erik Richter, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268353
- Sponsor's protocol ID
- 109324-1
- Acronym
- CAP
- Status last verified
- May 2024
- First submitted
- 12 Feb 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Plasma Concentration of CAPGDF15 Increased in Pregnancy? A Pilot Study
- ClinicalTrials.gov ID
- NCT06268353
- Acronym / sponsor ID
- CAP / 109324-1
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-pregnant controls and pregnant women
| Arm | Type | Receives |
|---|---|---|
| pregnancy | Experimental | Other: blood samplingNon-pregnant and pregnant women are compared |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Ongoing illness and/or medication intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingMeasure CAPGDF15 in plasma of 3 pregnant and 3 non-pregnant women | Other | pregnancy |
Primary outcome
CAPGDF15 levels in plasma
Time frame: 1 year
single sample
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Pregnancy Related, run by University of Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erik A Richter, MD (+4528751626, erichter@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAPGDF15 levels in plasma (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.