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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2024-05-20', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vaspin level in serum and placenta', 'timeFrame': 'one year', 'description': '\\- measure level of vaspin in serum as well as its level in placenta in patients with pre-eclampsia and women with normal pregnancy'}, {'measure': 'level of bcl2 expression in placenta', 'timeFrame': 'one year', 'description': 'measure level of gene expression of apoptotic marker bcl2 by PCR in placenta in patients with preeclampsia and women with normal pregnancy'}, {'measure': 'vaspin and bcl2', 'timeFrame': 'one year', 'description': 'correlation between level of vaspin and bcl2 gene expression in patients of preeclamsia and women with normal pregnancy'}], 'secondaryOutcomes': [{'measure': 'vapin level and bcl2 level and patient demographic data', 'timeFrame': 'one year', 'description': 'Correlation between vaspin level and bcl2 level with patient demographic data(Age -parity).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre-Eclampsia']}, 'referencesModule': {'references': [{'pmid': '31375930', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '37123551', 'type': 'BACKGROUND', '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.'}, {'pmid': '34359881', 'type': 'BACKGROUND', '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.'}, {'pmid': '31752432', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '* To investigate the possible role of vaspin and apoptosis in pre-eclamptic obese women .\n* To compare the serum as well as placental level of vaspin in normotensive and severe pre-eclamptic obese women.\n* To compare the serum as well as placental level of vaspin in normotensive normal body weight and severe pre-eclamptic obese women women .\n* To compare placental apoptosis marker Bcl2 in normotensive and severe pre-eclamptic obese women .\n* To compare placental apoptosis marker Bcl2 in normotensive normal body weight and severe pre-eclamptic obese women .\n* Correlation between vaspin and apoptosis in pre-eclamptic obese women .\n* Correlation between vaspin level and apoptosis marker with patient demographic data(Age -parity).', 'detailedDescription': '• 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women who will come for termination of pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Pregnant women who will come to hospital for termination of pregnancy .\n* Confirmed diagnosis of preeclampsia for study groups.\n* Control group will include Normotensive pregnant women.\n* Age group 18-35 years.\n* gestional age at termination of pregnancy : group 1\\&2 : from 38 to 40 weeks group 3:terminatin of pregnancy regardless of gestional age\n\nExclusion Criteria:\n\n* Pregnant women who do not consent to participate.\n* Diabeteic patients .\n* History of pre-gestional hypertension.\n* History of chronic renal disease.'}, 'identificationModule': {'nctId': 'NCT06437535', 'briefTitle': 'Role of Vaspin in Pathophysiology of Pre-eclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Pathophysiological Role of Vaspin and Apoptosis in Pre-eclamptic Obese Women', 'orgStudyIdInfo': {'id': 'vaspin and pre-eclampsia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'will include 25 women with normal weight and normal blood pressure .'}, {'label': 'Group2', 'description': ':will include 25 obsese women with normal blood pressure.'}, {'label': 'Group 3', 'description': ': will include 25 obese women with confirmed diagnosis of severe preeclampsia .'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aya ali ibrahim sayed, master', 'role': 'CONTACT', 'email': 'ayaa.alii2468@gmail.com', 'phone': '+20 010096908832'}, {'name': 'Mahmoud Raafat Abdel-fadeil, professor', 'role': 'CONTACT', 'email': 'mrafadeil@gmail.com', 'phone': '+20 01001644429'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Aya Ali Ibrahim Sayed', 'investigatorAffiliation': 'Assiut University'}}}}