Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in Preeclampsia

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.

Study Overview

• Status: Completed
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Diagnostic test: Serum asymmetteric dimethyl arginine; Diagnostic test: serum lipid profiles; Diagnostic test: Serum vaspin; Diagnostic test: Serum resistin

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 Type: Observational
• Enrollment (Actual): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-pregnant women (group 1); 20 non-pregnant women who serve as a control group (group 1)	Diagnostic test: Serum asymmetteric dimethyl arginine; Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay; Other Names: ADMA; Diagnostic test: serum lipid profiles; 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; Other Names: Lipids; Diagnostic test: Serum vaspin; vaspin concentrations will be assayed using commercially available ELISA kits; Diagnostic test: Serum resistin; resistin concentrations will be assayed using commercially available ELISA kits
pregnant women (group 2); 20 pregnant women with normal pregnancy at their third trimesters (group 2)	Diagnostic test: Serum asymmetteric dimethyl arginine; Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay; Other Names: ADMA; Diagnostic test: serum lipid profiles; 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; Other Names: Lipids; Diagnostic test: Serum vaspin; vaspin concentrations will be assayed using commercially available ELISA kits; Diagnostic test: Serum resistin; resistin concentrations will be assayed using commercially available ELISA kits
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.	Diagnostic test: Serum asymmetteric dimethyl arginine; Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay; Other Names: ADMA; Diagnostic test: serum lipid profiles; 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; Other Names: Lipids; Diagnostic test: Serum vaspin; vaspin concentrations will be assayed using commercially available ELISA kits; Diagnostic test: Serum resistin; resistin concentrations will be assayed using commercially available ELISA kits

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General 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.
• Jahromi 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2016
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Pregnancy Complications; Hypertension, Pregnancy-Induced; Inflammation; Insulin Resistance; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: CP0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No