Pre-EclampsiaNCT06437535
Role of Vaspin in Pathophysiology of Pre-eclampsia
An observational study of Pre-Eclampsia, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pre-Eclampsia
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women who will come for termination of pregnancy
Who may be able to join
- 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
Who cannot join
- Pregnant women who do not consent to participate.
- Diabeteic patients .
- History of pre-gestional hypertension.
- History of chronic renal disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Pathophysiological Role of Vaspin and Apoptosis in Pre-eclamptic Obese Women
- 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).
Read the 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.
- Conditions
- Pre-Eclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | will include 25 women with normal weight and normal blood pressure . | |
| Group2 | :will include 25 obsese women with normal blood pressure. | |
| Group 3 | : will include 25 obese women with confirmed diagnosis of severe preeclampsia . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
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
Measured: one year
vaspin and bcl2
correlation between level of vaspin and bcl2 gene expression in patients of preeclamsia and women with normal pregnancy
Measured: one year
Secondary outcomes (1)
vapin level and bcl2 level and patient demographic data
Correlation between vaspin level and bcl2 level with patient demographic data(Age -parity).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ali Ibrahim Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437535
- Sponsor's protocol ID
- vaspin and pre-eclampsia
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31375930Fondjo 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.
PubMed 37123551Kurowska 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.
PubMed 34359881Kurowska 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.
PubMed 31752432
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pathophysiological Role of Vaspin and Apoptosis in Pre-eclamptic Obese Women
- ClinicalTrials.gov ID
- NCT06437535
- Acronym / sponsor ID
- vaspin and pre-eclampsia
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –will include 25 women with normal weight and normal blood pressure . |
| Group2 | – | –:will include 25 obsese women with normal blood pressure. |
| Group 3 | – | –: will include 25 obese women with confirmed diagnosis of severe preeclampsia . |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women who will come for termination of pregnancy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant women who do not consent to participate.
- Diabeteic patients .
- History of pre-gestional hypertension.
- History of chronic renal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vaspin level in serum and placenta
Time frame: one year
- measure level of vaspin in serum as well as its level in placenta in patients with pre-eclampsia and women with normal pregnancy
level of bcl2 expression in placenta
Time frame: one year
measure level of gene expression of apoptotic marker bcl2 by PCR in placenta in patients with preeclampsia and women with normal pregnancy
vaspin and bcl2
Time frame: one year
correlation between level of vaspin and bcl2 gene expression in patients of preeclamsia and women with normal pregnancy
1 secondary outcome
vapin level and bcl2 level and patient demographic data
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Background: PubMed 31375930Bergman 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.
- Background: PubMed 37123551Fondjo 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.
- Background: PubMed 34359881Kurowska 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.
- Background: PubMed 31752432Kurowska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya ali ibrahim sayed, master (+20 010096908832, ayaa.alii2468@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaspin level in serum and placenta (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06437535, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.