Gasdermin-D and Pannexin-1 in Pregnancy
Primary Purpose
Pregnancy Complications, Maternal Obesity
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Biomarker measurement of pannexin-1 and gasdermin-D
Sponsored by
About this trial
This is an interventional basic science trial for Pregnancy Complications focused on measuring gasdermin-D, pannexin-1, placenta, omental tissue, fat tissue, maternal obesity, inflammation, oxidative stress, biochemistry, ELISA
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Intrauterine surgical procedure
- Presence of prenatal placental structural disorder
- Multiple pregnancies
Sites / Locations
- Haseki Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Normal Weight Pregnant Women
Overweight Pregnant Women
Obese Pregnant Women
Arm Description
The women who had term pregnancy and had normal BMI.
The women who had term pregnancy and had BMI values between 25-30.
The women who had term pregnancy, and had BMI values more than 30.
Outcomes
Primary Outcome Measures
Prediction of macrosomy
Prediction of macrosomy will be assesed by meaningfull increases of studied biomarkers Gasdermin-D and Pannexin-1
Secondary Outcome Measures
Full Information
NCT ID
NCT05475951
First Posted
July 6, 2022
Last Updated
July 25, 2022
Sponsor
Haseki Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05475951
Brief Title
Gasdermin-D and Pannexin-1 in Pregnancy
Official Title
Investigation of Gasdermin-D and Pannexin-1 in Fat and Placental Tissues in Pregnant Women With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haseki Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications, Maternal Obesity
Keywords
gasdermin-D, pannexin-1, placenta, omental tissue, fat tissue, maternal obesity, inflammation, oxidative stress, biochemistry, ELISA
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal Weight Pregnant Women
Arm Type
Experimental
Arm Description
The women who had term pregnancy and had normal BMI.
Arm Title
Overweight Pregnant Women
Arm Type
Experimental
Arm Description
The women who had term pregnancy and had BMI values between 25-30.
Arm Title
Obese Pregnant Women
Arm Type
Experimental
Arm Description
The women who had term pregnancy, and had BMI values more than 30.
Intervention Type
Diagnostic Test
Intervention Name(s)
Biomarker measurement of pannexin-1 and gasdermin-D
Intervention Description
These biomarkers were measured in the placental and adipose tissues of the participants.
Primary Outcome Measure Information:
Title
Prediction of macrosomy
Description
Prediction of macrosomy will be assesed by meaningfull increases of studied biomarkers Gasdermin-D and Pannexin-1
Time Frame
7 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Intrauterine surgical procedure
Presence of prenatal placental structural disorder
Multiple pregnancies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Cetin, Professor
Organizational Affiliation
Departmant of Obstetrics and Gynecology in Hasek, Training and Research Hospital, Istanbul, Turkey
Official's Role
Study Director
Facility Information:
Facility Name
Haseki Training and Research Hospital
City
Sultangazi
State/Province
İstanbul
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31505789
Citation
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.
Results Reference
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PubMed Identifier
31940889
Citation
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.
Results Reference
background
PubMed Identifier
31690840
Citation
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.
Results Reference
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PubMed Identifier
33152658
Citation
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.
Results Reference
background
PubMed Identifier
32555186
Citation
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.
Results Reference
background
PubMed Identifier
32838805
Citation
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.
Results Reference
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PubMed Identifier
30902848
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
result
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Gasdermin-D and Pannexin-1 in Pregnancy
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