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Pregnancy ComplicationsNCT05475951

Gasdermin-D and Pannexin-1 in Pregnancy

A study testing Biomarker measurement of pannexin-1 and gasdermin-D in people with Pregnancy Complications and Maternal Obesity, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

One -third of fertile women around the world are overweight or obese. This means increasing risk for both the mother and the child. Fat tissue is a factor in gestational DM development and the increase in material inflammation and oxidative stress. Read more about this study

Who is it for?
Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Complications, Maternal Obesity
What is being tested?
Biomarker measurement of pannexin-1 and gasdermin-D
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2021to 30 May 2022
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 20 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Being in the 20-35 age range
  • Term pregnancy (37-41 weeks)
  • Healthy pregnancy follow-up
  • Planned cesarean section
  • Having no complication in cesarean delivery
  • Being a placenta with front or rear walls

Who cannot join

  • Intrauterine surgical procedure
  • Presence of prenatal placental structural disorder
  • Multiple pregnancies

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Haseki Training and Research Hospital

    Sultangazi, Istanbul, 34000

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of Gasdermin-D and Pannexin-1 in Fat and Placental Tissues in Pregnant Women With Obesity

One -third of fertile women around the world are overweight or obese. This means increasing risk for both the mother and the child. Fat tissue is a factor in gestational DM development and the increase in material inflammation and oxidative stress. According to new knowledge, it is an important need to examine molecules that are not handled in new and human research in these mechanisms in fat and placenta tissues in obesity. For this purpose, the examination of the expression of gasdermin-D and pannex-1 proteins, which are shown to be produced in the cells of both tissues, is worth investigating in human fat tissue and placenta. Gasdermins and pannexins are proteins intersecting by interacting in cellular functions.

Gasdermins cause piroptosis, a type of litic proinflammatory cell death. Pannexin-1 plays in various cellular functions, including inflammation. These are examined in a small number of in vitro studies in material fat tissue and placenta, and the design of this study in people whose applications are applied is original in humans.

The status of the expressions of the gasdermin-D and pannexin-1 proteins, which will be examined for the first time in obese pregnant women's fat and placental tissues, are the subject of this research with each other and their relationship with other maternal and neonatal data.

Being tested
Biomarker measurement of pannexin-1 and gasdermin-D
Keywords
gasdermin-D, pannexin-1, placenta, omental tissue, fat tissue, maternal obesity, inflammation, oxidative stress, biochemistry, ELISA
Medical subject headings
Pregnancy Complications, Pregnancy in Obesity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biomarker measurement of pannexin-1 and gasdermin-DDiagnostic test

    These biomarkers were measured in the placental and adipose tissues of the participants.

Study groups in NCT05475951
Study groupRoleWhat they receive
Normal Weight Pregnant WomenExperimentalThe women who had term pregnancy and had normal BMI.
Receives: Diagnostic Test: Biomarker measurement of pannexin-1 and gasdermin-D
Overweight Pregnant WomenExperimentalThe women who had term pregnancy and had BMI values between 25-30.
Receives: Diagnostic Test: Biomarker measurement of pannexin-1 and gasdermin-D
Obese Pregnant WomenExperimentalThe women who had term pregnancy, and had BMI values more than 30.
Receives: Diagnostic Test: Biomarker measurement of pannexin-1 and gasdermin-D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prediction of macrosomy

    Prediction of macrosomy will be assesed by meaningfull increases of studied biomarkers Gasdermin-D and Pannexin-1

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2022
  2. Study start1 Dec 2021
  3. Primary completion15 May 2022
  4. Study completion30 May 2022

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05475951
Sponsor's protocol ID
95932
Status last verified
May 2022
First submitted
6 Jul 2022
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Estienne A, Bongrani A, Reverchon M, Rame C, Ducluzeau PH, Froment P, Dupont J. Involvement of Novel Adipokines, Chemerin, Visfatin, Resistin and Apelin in Reproductive Functions in Normal and Pathological Conditions in Humans and Animal Models. Int J Mol Sci. 2019 Sep 9;20(18):4431. doi: 10.3390/ijms20184431.

    PubMed 31505789

  • Rancourt RC, Ott R, Ziska T, Schellong K, Melchior K, Henrich W, Plagemann A. Visceral Adipose Tissue Inflammatory Factors (TNF-Alpha, SOCS3) in Gestational Diabetes (GDM): Epigenetics as a Clue in GDM Pathophysiology. Int J Mol Sci. 2020 Jan 12;21(2):479. doi: 10.3390/ijms21020479.

    PubMed 31940889

  • Broz P, Pelegrin P, Shao F. The gasdermins, a protein family executing cell death and inflammation. Nat Rev Immunol. 2020 Mar;20(3):143-157. doi: 10.1038/s41577-019-0228-2. Epub 2019 Nov 5.

    PubMed 31690840

  • Abrahams VM, Tang Z, Mor G, Guller S. NLRP3 inflammasome function and pyroptotic cell death in human placental Hofbauer cells. J Reprod Immunol. 2020 Nov;142:103214. doi: 10.1016/j.jri.2020.103214. Epub 2020 Oct 3.

    PubMed 33152658

  • Zhang C, Zhao C, Chen X, Tao R, Wang S, Meng G, Liu X, Shao C, Su X. Induction of ASC pyroptosis requires gasdermin D or caspase-1/11-dependent mediators and IFNbeta from pyroptotic macrophages. Cell Death Dis. 2020 Jun 18;11(6):470. doi: 10.1038/s41419-020-2664-0.

    PubMed 32555186

  • Dye ZT, Rutledge LV, Penuela S, Dyce PW. Pannexin 1 inhibition delays maturation and improves development of Bos taurus oocytes. J Ovarian Res. 2020 Aug 24;13(1):98. doi: 10.1186/s13048-020-00704-w.

    PubMed 32838805

  • Chen KW, Demarco B, Heilig R, Shkarina K, Boettcher A, Farady CJ, Pelczar P, Broz P. Extrinsic and intrinsic apoptosis activate pannexin-1 to drive NLRP3 inflammasome assembly. EMBO J. 2019 May 15;38(10):e101638. doi: 10.15252/embj.2019101638. Epub 2019 Mar 22.

    PubMed 30902848

  • Korac A, Srdic-Galic B, Kalezic A, Stancic A, Otasevic V, Korac B, Jankovic A. Adipokine signatures of subcutaneous and visceral abdominal fat in normal-weight and obese women with different metabolic profiles. Arch Med Sci. 2021 Feb 26;17(2):323-336. doi: 10.5114/aoms/92118. eCollection 2021.

    PubMed 33747267

  • Stubert J, Reister F, Hartmann S, Janni W. The Risks Associated With Obesity in Pregnancy. Dtsch Arztebl Int. 2018 Apr 20;115(16):276-283. doi: 10.3238/arztebl.2018.0276.

    PubMed 29739495

  • Poston L, Harthoorn LF, Van Der Beek EM; Contributors to the ILSI Europe Workshop. Obesity in pregnancy: implications for the mother and lifelong health of the child. A consensus statement. Pediatr Res. 2011 Feb;69(2):175-80. doi: 10.1203/PDR.0b013e3182055ede.

    PubMed 21076366

  • Tozzi M, Hansen JB, Novak I. Pannexin-1 mediated ATP release in adipocytes is sensitive to glucose and insulin and modulates lipolysis and macrophage migration. Acta Physiol (Oxf). 2020 Feb;228(2):e13360. doi: 10.1111/apha.13360. Epub 2019 Oct 14.

    PubMed 31400255

Questions about this trial

What is this clinical trial studying?

A study testing Biomarker measurement of pannexin-1 and gasdermin-D in people with Pregnancy Complications and Maternal Obesity, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).

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 6 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prediction of macrosomy (time frame: 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05475951, which also lists 11 linked publications.

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 27 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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