Clinical trial NCT04455204: Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in Preeclampsia
Official title: Implication of Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in the Pathogenesis of Preeclampsia and in Pregnancy Related Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Eclampsia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Interleukin 18
timeFrame: Nine months
measure: Vaspin level
timeFrame: Nine months
measure: resistin level
timeFrame: Nine months
measure: Malondialdehyde level
timeFrame: Nine Months
measure: Serum asymmetteric dimethyl arginine (ADMA)
timeFrame: Nine Months
measure: insulin resistance (IR)
timeFrame: Nine Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tanta University
name: Tarek M Mostafa, Ass. Prof.
role: STUDY_DIRECTOR
References:
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.
citation: 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.