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

NCT06268353 | Recruiting

• 1 other identifier: 109324-1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• CAPGDF15 levels in plasma

  single sample

  1 year

Study Arms (1)

pregnancy

EXPERIMENTAL

Non-pregnant and pregnant women are compared

Other: blood sampling

Interventions

blood sampling OTHER

Measure CAPGDF15 in plasma of 3 pregnant and 3 non-pregnant women

pregnancy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Ongoing illness and/or medication intake

Sponsors & Collaborators

• University of Copenhagen: lead
• Stanford University: collaborator

Study Sites (2)

August Krogh Building

Copenhagen, 2100, Denmark

RECRUITING

University of Copenhagen, August Krogh Section for Molecular Physiology

Copenhagen, Østerbro, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Erik A Richter, MD

CONTACT

+4528751626; erichter@nexs.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD DMSci

Model Details: Non-pregnant controls and pregnant women

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: March 15, 2024
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)