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
1 other identifier
observational
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2016
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 29, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedJuly 7, 2020
July 1, 2020
3.4 years
June 29, 2020
July 2, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
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
Study Arms (3)
non-pregnant women (group 1)
20 non-pregnant women who serve as a control group (group 1)
pregnant women (group 2)
20 pregnant women with normal pregnancy at their third trimesters (group 2)
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.
Interventions
Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay
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
vaspin concentrations will be assayed using commercially available ELISA kits
resistin concentrations will be assayed using commercially available ELISA kits
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Related Publications (2)
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.
PMID: 24929806BACKGROUNDJahromi 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.
PMID: 24999311BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tarek M Mostafa, Ass. Prof.
Tanta University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 29, 2020
First Posted
July 2, 2020
Study Start
April 25, 2016
Primary Completion
September 30, 2019
Study Completion
October 1, 2019
Last Updated
July 7, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share