Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-02 @ 10:42 AM
Study NCT ID:
NCT06437535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Vaspin in Pathophysiology of Pre-eclampsia
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
The Pathophysiological Role of Vaspin and Apoptosis in Pre-eclamptic Obese Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
* 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).
Detailed 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: