NCT05475951

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
Last Updated

July 27, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

July 6, 2022

Last Update Submit

July 25, 2022

Conditions

Keywords

gasdermin-Dpannexin-1placentaomental tissuefat tissuematernal obesityinflammationoxidative stressbiochemistryELISA

Outcome Measures

Primary Outcomes (1)

  • Prediction of macrosomy

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

    7 months

Study Arms (3)

Normal Weight Pregnant Women

EXPERIMENTAL

The women who had term pregnancy and had normal BMI.

Diagnostic Test: Biomarker measurement of pannexin-1 and gasdermin-D

Overweight Pregnant Women

EXPERIMENTAL

The women who had term pregnancy and had BMI values between 25-30.

Diagnostic Test: Biomarker measurement of pannexin-1 and gasdermin-D

Obese Pregnant Women

EXPERIMENTAL

The women who had term pregnancy, and had BMI values more than 30.

Diagnostic Test: Biomarker measurement of pannexin-1 and gasdermin-D

Interventions

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

Normal Weight Pregnant WomenObese Pregnant WomenOverweight Pregnant Women

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Research Hospital

Sultangazi, Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

    PMID: 31505789BACKGROUND
  • 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.

    PMID: 31940889BACKGROUND
  • 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.

    PMID: 31690840BACKGROUND
  • 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.

    PMID: 33152658BACKGROUND
  • 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.

    PMID: 32555186BACKGROUND
  • 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.

    PMID: 32838805BACKGROUND
  • 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.

    PMID: 30902848BACKGROUND
  • 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.

    PMID: 33747267BACKGROUND
  • 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.

    PMID: 29739495BACKGROUND
  • 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.

    PMID: 21076366BACKGROUND
  • 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.

MeSH Terms

Conditions

Pregnancy ComplicationsPregnancy in ObesityInflammation

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Ali Cetin, Professor

    Departmant of Obstetrics and Gynecology in Hasek, Training and Research Hospital, Istanbul, Turkey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 27, 2022

Study Start

December 1, 2021

Primary Completion

May 15, 2022

Study Completion

May 30, 2022

Last Updated

July 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations