Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in Preeclampsia

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455204
• Other study ID #: CP0002
• Status: Completed
• Start date: April 25, 2016
• Est. completion date: October 1, 2019

Study information

• Verified date: July 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2019
• Est. primary completion date: September 30, 2019
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Inflammation
• Insulin Resistance
• Pre-Eclampsia

Intervention

Diagnostic Test:
• Serum asymmetteric dimethyl arginine
Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay
• 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
• Serum vaspin
vaspin concentrations will be assayed using commercially available ELISA kits
• Serum resistin
resistin concentrations will be assayed using commercially available ELISA kits

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

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