Role of Vaspin in Pathophysiology of Pre-eclampsia

Pre-Eclampsia Clinical Trial

Official title:

The Pathophysiological Role of Vaspin and Apoptosis in Pre-eclamptic Obese Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06437535
• Other study ID #: vaspin and pre-eclampsia
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Aya ali ibrahim sayed, master
• Phone: +20 010096908832
• Email: ayaa.alii2468[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• To investigate the possible role of vaspin and apoptosis in pre-eclamptic obese women .

• To compare the serum as well as placental level of vaspin in normotensive and severe pre-eclamptic obese women.

• To compare the serum as well as placental level of vaspin in normotensive normal body weight and severe pre-eclamptic obese women women .

• To compare placental apoptosis marker Bcl2 in normotensive and severe pre-eclamptic obese women .

• To compare placental apoptosis marker Bcl2 in normotensive normal body weight and severe pre-eclamptic obese women .

• Correlation between vaspin and apoptosis in pre-eclamptic obese women .

• Correlation between vaspin level and apoptosis marker with patient demographic data(Age -parity).

Description:

• Pre-eclampsia(PE) is defined as new onset hypertension after 20 weeks gestation with evidence of maternal organ or uteroplacental dysfunction or proteinuria. The majority of maternal deaths related to PE can be avoided by providing timely and effective care and delivery to high-risk women. Thus, optimization of health care for women during pregnancy to prevent and treat PE . PE classified clinically to mild and severe sub types as Pregnant women with BP≥160/110 mmHg and proteinuria ≥3+ reading on dipstick are classified as having severe PE while pregnant women with systolic blood pressure of 140 -159 mmHg, diastolic blood pressure of 90-109 mmHg, and proteinuria ≥1+ reading on dipstick are classified as having mild PE.. Vaspin, a member of adipokines was first isolated from the visceral adipose tissue of the rat abdominal obesity model (OLETF). It belongs to the serine protease inhibitors and acts through a protein G-coupled receptor - GRP78. Vaspin has also found in the liver, pancreas, cerebrospinal fluid, hypothalamus, intestine, and lungs.it has pleiotropic functions that include regulating inflammatory response, insulin resistance and the development of obesity. Vaspin like other adipokines including leptin and adiponectin can affect the female reproduction system like ovary. Vaspin expression was detected in another reproductive component, the placenta. In humans, vaspin was localized in cytotrophoblasts and syncytiotrophoblasts in first-trimester placentas, but only in syncytiotrophoblasts in third-trimester placentas. Apoptosis plays a critical role in the homeostasis regulation of normal placental development. However, excessive placental apoptosis leads to placental dysfunction, which may consequence in pregnancy disorders such as preeclampsia. vaspin acts as an antiapoptotic agent in ovary by attenuating the tumor necrosis factor (TNF-α)-induced apoptosis by promoting autophagy also has been shown to inhibit macrophage apoptosisAnti apoptotic effects of vaspin have also been described in human osteoblast cells by upregulation of the expression of BCL2 and downregulation of BAX through the Mitogen-activated kinase (MAP3/1)pathway and Protein kinase B(AKT) pathway.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: August 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion criteria:

• Pregnant women who will come to hospital for termination of pregnancy .

• Confirmed diagnosis of preeclampsia for study groups.

• Control group will include Normotensive pregnant women.

• Age group 18-35 years.

• gestional age at termination of pregnancy : group 1&2 : from 38 to 40 weeks group 3:terminatin of pregnancy regardless of gestional age

Exclusion Criteria:

• Pregnant women who do not consent to participate.

• Diabeteic patients .

• History of pre-gestional hypertension.

• History of chronic renal disease.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Bergman L, Torres-Vergara P, Penny J, Wikstrom J, Nelander M, Leon J, Tolcher M, Roberts JM, Wikstrom AK, Escudero C. Investigating Maternal Brain Alterations in Preeclampsia: the Need for a Multidisciplinary Effort. Curr Hypertens Rep. 2019 Aug 2;21(9):72. doi: 10.1007/s11906-019-0977-0. — View Citation

Fondjo LA, Sarpong D, Owiredu WKBA, Opoku S, Adu-Bonsaffoh K, Teviu E. Effect of magnesium sulfate treatment on mediators of endothelial dysfunction and electrolytes in mild and severe preeclampsia: A case-control study. Health Sci Rep. 2023 Apr 26;6(5):e1232. doi: 10.1002/hsr2.1232. eCollection 2023 May. — View Citation

Kurowska P, Mlyczynska E, Dawid M, Jurek M, Klimczyk D, Dupont J, Rak A. Review: Vaspin (SERPINA12) Expression and Function in Endocrine Cells. Cells. 2021 Jul 6;10(7):1710. doi: 10.3390/cells10071710. — View Citation

Kurowska P, Mlyczynska E, Dawid M, Opydo-Chanek M, Dupont J, Rak A. In Vitro Effects of Vaspin on Porcine Granulosa Cell Proliferation, Cell Cycle Progression, and Apoptosis by Activation of GRP78 Receptor and Several Kinase Signaling Pathways Including MAP3/1, AKT, and STAT3. Int J Mol Sci. 2019 Nov 19;20(22):5816. doi: 10.3390/ijms20225816. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vaspin level in serum and placenta	- measure level of vaspin in serum as well as its level in placenta in patients with pre-eclampsia and women with normal pregnancy	one year
Primary	level of bcl2 expression in placenta	measure level of gene expression of apoptotic marker bcl2 by PCR in placenta in patients with preeclampsia and women with normal pregnancy	one year
Primary	vaspin and bcl2	correlation between level of vaspin and bcl2 gene expression in patients of preeclamsia and women with normal pregnancy	one year
Secondary	vapin level and bcl2 level and patient demographic data	Correlation between vaspin level and bcl2 level with patient demographic data(Age -parity).	one year