Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in Preeclampsia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Implication of Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in the Pathogenesis of Preeclampsia and in Pregnancy Related Complications

Conditions
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Pre-Eclampsia

Intervention / Treatment
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* Diagnostic Test: Serum asymmetteric dimethyl arginine
* Diagnostic Test: serum lipid profiles
* Diagnostic Test: Serum vaspin
* Diagnostic Test: Serum resistin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-pregnant women (group 1)<br>20 non-pregnant women who serve as a control group (group 1) | Diagnostic Test: Serum asymmetteric dimethyl arginine<br>* Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay<br>* Other names: ADMA;Diagnostic Test: serum lipid profiles<br>* 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<br>* Other names: Lipids;Diagnostic Test: Serum vaspin<br>* vaspin concentrations will be assayed using commercially available ELISA kits<br>Diagnostic Test: Serum resistin<br>* resistin concentrations will be assayed using commercially available ELISA kits<br>|
| pregnant women (group 2)<br>20 pregnant women with normal pregnancy at their third trimesters (group 2) | Diagnostic Test: Serum asymmetteric dimethyl arginine<br>* Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay<br>* Other names: ADMA;Diagnostic Test: serum lipid profiles<br>* 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<br>* Other names: Lipids;Diagnostic Test: Serum vaspin<br>* vaspin concentrations will be assayed using commercially available ELISA kits<br>Diagnostic Test: Serum resistin<br>* resistin concentrations will be assayed using commercially available ELISA kits<br>|
| pregnant women with Preeclampsia (group 3)<br>20 pregnant women with Preeclampsia in their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria. | Diagnostic Test: Serum asymmetteric dimethyl arginine<br>* Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay<br>* Other names: ADMA;Diagnostic Test: serum lipid profiles<br>* 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<br>* Other names: Lipids;Diagnostic Test: Serum vaspin<br>* vaspin concentrations will be assayed using commercially available ELISA kits<br>Diagnostic Test: Serum resistin<br>* resistin concentrations will be assayed using commercially available ELISA kits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin 18 | IL-18 will be carried out using Enzyme-Linked Immunosorbent Assay | Nine months | 
| Vaspin level | Serum vaspin concentrations will be assayed using commercially available ELISA kits | Nine months | 
| resistin level | Serum resistin concentrations will be assayed using commercially available ELISA kits | Nine months | 
| Malondialdehyde level | MDA will be measured spectrophotometrically | Nine Months | 
| Serum asymmetteric dimethyl arginine (ADMA) | Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay | 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). | Nine Months |