Pre-EclampsiaNCT04455204
Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in Preeclampsia
An observational study of Pre-Eclampsia, run by Tanta University.
Trial summary
The aim of the present study is to evaluate the implication of adipokines, inflammation, insulin resistance and endothelial dysfunction in the pathogenesis of preeclampsia and in pregnancy related complications. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Serum asymmetteric dimethyl arginine, serum lipid profiles and Serum vaspin
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2016to 1 Oct 2019
- 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 25 to 35 years
- Women only
- Adult
Study population: total number of 60 women who will be further classified into: 20 non-pregnant women who serve as control group (group 1), 20 pregnant women with normal pregnancy at their third trimesters (group 2) and 20 pregnant women with Preeclampsia at their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria. The pregnant women will be assessed in their third trimesters and further re-evaluated 4 weeks after delivery. The gestational ages will be determined conventionally and re-affirmed by ultrasonographic measurement.
Who may be able to join
- Pregnant women with normal pregnancy (n=20)
- Pregnant women with Preeclampsia (n=20) at their third trimesters of pregnancy will be included in the study. Preeclampsia will be defined and diagnosed by constant elevation in blood pressure greater than 140/90 mmHg and by the presence of proteinuria above 300 mg /24 hour with the absence of both urinary tract infection and previous history of hypertension.
- Apparently healthy non-pregnant females (n=20) will be included in this study also.
Who cannot join
- Women with risk factors for oxidative stress such as smokers and
- Those with a medical history of diabetes mellitus (DM) and Tuberculosis (T.B).
- Women with a history of hypertension, familial hyperlipidemia, liver diseases, inflammatory diseases, and renal impairment.
- Non-pregnant women on hormonal therapy or hormonal contraceptives.
About this study
Official title: Implication of Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in the Pathogenesis of Preeclampsia and in Pregnancy Related Complications
The aim of the present study is to evaluate the implication of adipokines, inflammation, insulin resistance and endothelial dysfunction in the pathogenesis of preeclampsia and in pregnancy related complications.
Read the detailed description
This observational parallel study will be conducted on pregnant women with normal pregnancy, pregnant women with Preeclampsia, and on healthy non-pregnant women. All participants will be recruited from the Outpatient Clinic of Obstetrics and Gynecology Department at Menoufia University Hospital (Shebin El-Kom, Egypt). The study will be approved by the Research Ethics Committee of Menoufia University and all the involved subjects will give their written informed consent.
This study will involve a total number of 60 women who will be further classified into: 20 non-pregnant women who serve as the control group (group 1), 20 pregnant women with normal pregnancy at their third trimesters (group 2) and 20 pregnant women with Preeclampsia at their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria. The pregnant women will be assessed in their third trimesters and further re-evaluated 4 weeks after delivery. The gestational ages will be determined conventionally and re-affirmed by ultrasonographic measurement.
- Conditions
- Pre-Eclampsia
- Being tested
- Serum asymmetteric dimethyl arginine, serum lipid profiles, Serum vaspin, Serum resistin
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum asymmetteric dimethyl arginineDiagnostic test
Also called ADMA
Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay
serum lipid profilesDiagnostic test
Also called Lipids
serum lipid profiles including triglycerides (TG), total cholesterol and high-density lipoprotein cholesterol (HDL-C) which will be measured by enzymatic colorimetric method) using commercial kits
Serum vaspinDiagnostic test
vaspin concentrations will be assayed using commercially available ELISA kits
Serum resistinDiagnostic test
resistin concentrations will be assayed using commercially available ELISA kits
| Study group | Role | What they receive |
|---|---|---|
| non-pregnant women (group 1) | 20 non-pregnant women who serve as a control group (group 1) Receives: Diagnostic Test: Serum asymmetteric dimethyl arginine; Diagnostic Test: serum lipid profiles; Diagnostic Test: Serum vaspin; Diagnostic Test: Serum resistin | |
| pregnant women (group 2) | 20 pregnant women with normal pregnancy at their third trimesters (group 2) Receives: Diagnostic Test: Serum asymmetteric dimethyl arginine; Diagnostic Test: serum lipid profiles; Diagnostic Test: Serum vaspin; Diagnostic Test: Serum resistin | |
| pregnant women with Preeclampsia (group 3) | 20 pregnant women with Preeclampsia in their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria. Receives: Diagnostic Test: Serum asymmetteric dimethyl arginine; Diagnostic Test: serum lipid profiles; Diagnostic Test: Serum vaspin; Diagnostic Test: Serum resistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin 18
IL-18 will be carried out using Enzyme-Linked Immunosorbent Assay
Measured: Nine months
Vaspin level
Serum vaspin concentrations will be assayed using commercially available ELISA kits
Measured: Nine months
resistin level
Serum resistin concentrations will be assayed using commercially available ELISA kits
Measured: Nine months
Malondialdehyde level
MDA will be measured spectrophotometrically
Measured: Nine Months
Serum asymmetteric dimethyl arginine (ADMA)
Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay
Measured: Nine Months
insulin resistance (IR)
insulin resistance (IR) using the HOMA-IR index [18], which is defined as fasting insulin (μIU/ml) times fasting glucose (mmol/l) divided by 22.5 or divided by 405 if fasting blood glucose is expressed in mass units (mg/dl).
Measured: Nine Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start25 Apr 2016
- Primary completion30 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Tanta 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tarek Mohamed Mostafa, Tanta University
- Investigators
- Tarek M Mostafa, Ass. Prof., Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455204
- Sponsor's protocol ID
- CP0002
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jia X, Wang S, Ma N, Li X, Guo L, Liu X, Dong T, Liu Y, Lu Q. Comparative analysis of vaspin in pregnant women with and without gestational diabetes mellitus and healthy non-pregnant women. Endocrine. 2015 Mar;48(2):533-40. doi: 10.1007/s12020-014-0318-7. Epub 2014 Jun 15.
PubMed 24929806Jahromi AS, Shojaei M, Ghobadifar MA. Insulin resistance and serum levels of interleukin-17 and interleukin-18 in normal pregnancy. Immune Netw. 2014 Jun;14(3):149-55. doi: 10.4110/in.2014.14.3.149. Epub 2014 Jun 19.
PubMed 24999311
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implication of Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in the Pathogenesis of Preeclampsia and in Pregnancy Related Complications
- ClinicalTrials.gov ID
- NCT04455204
- Acronym / sponsor ID
- CP0002
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 25 Apr 2016 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 2 Jul 2020 (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.
The aim of the present study is to evaluate the implication of adipokines, inflammation, insulin resistance and endothelial dysfunction in the pathogenesis of preeclampsia and in pregnancy related complications.
Detailed description
This observational parallel study will be conducted on pregnant women with normal pregnancy, pregnant women with Preeclampsia, and on healthy non-pregnant women. All participants will be recruited from the Outpatient Clinic of Obstetrics and Gynecology Department at Menoufia University Hospital (Shebin El-Kom, Egypt). The study will be approved by the Research Ethics Committee of Menoufia University and all the involved subjects will give their written informed consent.
This study will involve a total number of 60 women who will be further classified into: 20 non-pregnant women who serve as the control group (group 1), 20 pregnant women with normal pregnancy at their third trimesters (group 2) and 20 pregnant women with Preeclampsia at their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria. The pregnant women will be assessed in their third trimesters and further re-evaluated 4 weeks after delivery. The gestational ages will be determined conventionally and re-affirmed by ultrasonographic measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-pregnant women (group 1) | – | Diagnostic Test: Serum asymmetteric dimethyl arginine, Diagnostic Test: serum lipid profiles, Diagnostic Test: Serum vaspin, Diagnostic Test: Serum resistin20 non-pregnant women who serve as a control group (group 1) |
| pregnant women (group 2) | – | Diagnostic Test: Serum asymmetteric dimethyl arginine, Diagnostic Test: serum lipid profiles, Diagnostic Test: Serum vaspin, Diagnostic Test: Serum resistin20 pregnant women with normal pregnancy at their third trimesters (group 2) |
| pregnant women with Preeclampsia (group 3) | – | Diagnostic Test: Serum asymmetteric dimethyl arginine, Diagnostic Test: serum lipid profiles, Diagnostic Test: Serum vaspin, Diagnostic Test: Serum resistin20 pregnant women with Preeclampsia in their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- total number of 60 women who will be further classified into: 20 non-pregnant women who serve as control group (group 1), 20 pregnant women with normal pregnancy at their third trimesters (group 2) and 20 pregnant women with Preeclampsia at their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria. The pregnant women will be assessed in their third trimesters and further re-evaluated 4 weeks after delivery. The gestational ages will be determined conventionally and re-affirmed by ultrasonographic measurement.
Key inclusion criteria (3 listed)
- Pregnant women with normal pregnancy (n=20)
- Pregnant women with Preeclampsia (n=20) at their third trimesters of pregnancy will be included in the study. Preeclampsia will be defined and diagnosed by constant elevation in blood pressure greater than 140/90 mmHg and by the presence of proteinuria above 300 mg /24 hour with the absence of both urinary tract infection and previous history of hypertension.
- Apparently healthy non-pregnant females (n=20) will be included in this study also.
Key exclusion criteria (4 listed)
- Women with risk factors for oxidative stress such as smokers and
- Those with a medical history of diabetes mellitus (DM) and Tuberculosis (T.B).
- Women with a history of hypertension, familial hyperlipidemia, liver diseases, inflammatory diseases, and renal impairment.
- Non-pregnant women on hormonal therapy or hormonal contraceptives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum asymmetteric dimethyl arginineAlso: ADMASerum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay | Diagnostic test | non-pregnant women (group 1), pregnant women (group 2), pregnant women with Preeclampsia (group 3) |
| serum lipid profilesAlso: Lipidsserum lipid profiles including triglycerides (TG), total cholesterol and high-density lipoprotein cholesterol (HDL-C) which will be measured by enzymatic colorimetric method) using commercial kits | Diagnostic test | non-pregnant women (group 1), pregnant women (group 2), pregnant women with Preeclampsia (group 3) |
| Serum vaspinvaspin concentrations will be assayed using commercially available ELISA kits | Diagnostic test | non-pregnant women (group 1), pregnant women (group 2), pregnant women with Preeclampsia (group 3) |
| Serum resistinresistin concentrations will be assayed using commercially available ELISA kits | Diagnostic test | non-pregnant women (group 1), pregnant women (group 2), pregnant women with Preeclampsia (group 3) |
Primary outcome
Interleukin 18
Time frame: Nine months
IL-18 will be carried out using Enzyme-Linked Immunosorbent Assay
Vaspin level
Time frame: Nine months
Serum vaspin concentrations will be assayed using commercially available ELISA kits
resistin level
Time frame: Nine months
Serum resistin concentrations will be assayed using commercially available ELISA kits
Malondialdehyde level
Time frame: Nine Months
MDA will be measured spectrophotometrically
Serum asymmetteric dimethyl arginine (ADMA)
Time frame: Nine Months
Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay
insulin resistance (IR)
Time frame: Nine Months
insulin resistance (IR) using the HOMA-IR index [18], which is defined as fasting insulin (μIU/ml) times fasting glucose (mmol/l) divided by 22.5 or divided by 405 if fasting blood glucose is expressed in mass units (mg/dl).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Background: PubMed 24929806Jia X, Wang S, Ma N, Li X, Guo L, Liu X, Dong T, Liu Y, Lu Q. Comparative analysis of vaspin in pregnant women with and without gestational diabetes mellitus and healthy non-pregnant women. Endocrine. 2015 Mar;48(2):533-40. doi: 10.1007/s12020-014-0318-7. Epub 2014 Jun 15.
- Background: PubMed 24999311Jahromi AS, Shojaei M, Ghobadifar MA. Insulin resistance and serum levels of interleukin-17 and interleukin-18 in normal pregnancy. Immune Netw. 2014 Jun;14(3):149-55. doi: 10.4110/in.2014.14.3.149. Epub 2014 Jun 19.
- Individual participant dataSharing planned: No
Related trials for Pre-Eclampsia
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Tarek M Mostafa, Ass. Prof. study director
Tanta University
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by Tanta 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 3 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: finished, as of the sponsor's last update on 7 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin 18 (time frame: Nine months). The study lists 6 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 NCT04455204, which also lists 2 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 7 Jul 2020.