Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in Preeclampsia

Completed

• Conditions: Pre-Eclampsia
• Interventions: Diagnostic Test: Serum asymmetteric dimethyl arginine; Diagnostic Test: serum lipid profiles; Diagnostic Test: Serum vaspin; Diagnostic Test: Serum resistin

• Registration Number: NCT04455204
• Lead Sponsor: Tanta University

Brief 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.

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 Timeline

• Study Start: 2016-04-25
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-01
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-29
• Status Verified: 2020-07
• Study First Posted: 2020-07-02
• Last Update Submitted: 2020-07-02
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-pregnant women (group 1)	Serum asymmetteric dimethyl arginine	20 non-pregnant women who serve as a control group (group 1)
pregnant women with Preeclampsia (group 3)	serum lipid profiles	20 pregnant women with Preeclampsia in their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria.
pregnant women with Preeclampsia (group 3)	Serum vaspin	20 pregnant women with Preeclampsia in their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria.
non-pregnant women (group 1)	Serum vaspin	20 non-pregnant women who serve as a control group (group 1)
pregnant women (group 2)	Serum vaspin	20 pregnant women with normal pregnancy at their third trimesters (group 2)
pregnant women (group 2)	Serum asymmetteric dimethyl arginine	20 pregnant women with normal pregnancy at their third trimesters (group 2)
non-pregnant women (group 1)	serum lipid profiles	20 non-pregnant women who serve as a control group (group 1)
pregnant women (group 2)	serum lipid profiles	20 pregnant women with normal pregnancy at their third trimesters (group 2)
non-pregnant women (group 1)	Serum resistin	20 non-pregnant women who serve as a control group (group 1)
pregnant women (group 2)	Serum resistin	20 pregnant women with normal pregnancy at their third trimesters (group 2)
pregnant women with Preeclampsia (group 3)	Serum asymmetteric dimethyl arginine	20 pregnant women with Preeclampsia in their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria.
pregnant women with Preeclampsia (group 3)	Serum resistin	20 pregnant women with Preeclampsia in their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria.

Primary Outcome Measures

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