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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04455204
Enrollment
60
Registered
2020-07-02
Start date
2016-04-25
Completion date
2019-10-01
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Eclampsia

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.

Interventions

DIAGNOSTIC_TESTSerum asymmetteric dimethyl arginine

Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay

DIAGNOSTIC_TESTserum 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

DIAGNOSTIC_TESTSerum vaspin

vaspin concentrations will be assayed using commercially available ELISA kits

DIAGNOSTIC_TESTSerum resistin

resistin concentrations will be assayed using commercially available ELISA kits

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 35 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Interleukin 18Nine monthsIL-18 will be carried out using Enzyme-Linked Immunosorbent Assay
Vaspin levelNine monthsSerum vaspin concentrations will be assayed using commercially available ELISA kits
resistin levelNine monthsSerum resistin concentrations will be assayed using commercially available ELISA kits
Malondialdehyde levelNine MonthsMDA will be measured spectrophotometrically
Serum asymmetteric dimethyl arginine (ADMA)Nine MonthsSerum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay
insulin resistance (IR)Nine Monthsinsulin 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026