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NCT Number: NCT04455204

Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in Preeclampsia

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.

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Key information

Conditions

Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases

Age range

25 year–35 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Serum asymmetteric dimethyl arginine

Diagnostic Test

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

Other names: ADMA

serum lipid profiles

Diagnostic Test

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

Serum vaspin

Diagnostic Test

vaspin concentrations will be assayed using commercially available ELISA kits

Serum resistin

Diagnostic Test

resistin concentrations will be assayed using commercially available ELISA kits

Primary outcomes

  1. Interleukin 18

    Time frame: Nine months

    IL-18 will be carried out using Enzyme-Linked Immunosorbent Assay

  2. Vaspin level

    Time frame: Nine months

    Serum vaspin concentrations will be assayed using commercially available ELISA kits

  3. resistin level

    Time frame: Nine months

    Serum resistin concentrations will be assayed using commercially available ELISA kits

  4. Malondialdehyde level

    Time frame: Nine Months

    MDA will be measured spectrophotometrically

  5. Serum asymmetteric dimethyl arginine (ADMA)

    Time frame: Nine Months

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

  6. insulin resistance (IR)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2020
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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