Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in Preeclampsia

NCT ID: NCT04455204

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-25

Study Completion Date

2019-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pre-Eclampsia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

non-pregnant women (group 1)

20 non-pregnant women who serve as a control group (group 1)

Serum asymmetteric dimethyl arginine

Intervention Type DIAGNOSTIC_TEST

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

serum lipid profiles

Intervention Type 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

Serum vaspin

Intervention Type DIAGNOSTIC_TEST

vaspin concentrations will be assayed using commercially available ELISA kits

Serum resistin

Intervention Type DIAGNOSTIC_TEST

resistin concentrations will be assayed using commercially available ELISA kits

pregnant women (group 2)

20 pregnant women with normal pregnancy at their third trimesters (group 2)

Serum asymmetteric dimethyl arginine

Intervention Type DIAGNOSTIC_TEST

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

serum lipid profiles

Intervention Type 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

Serum vaspin

Intervention Type DIAGNOSTIC_TEST

vaspin concentrations will be assayed using commercially available ELISA kits

Serum resistin

Intervention Type DIAGNOSTIC_TEST

resistin concentrations will be assayed using commercially available ELISA kits

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.

Serum asymmetteric dimethyl arginine

Intervention Type DIAGNOSTIC_TEST

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

serum lipid profiles

Intervention Type 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

Serum vaspin

Intervention Type DIAGNOSTIC_TEST

vaspin concentrations will be assayed using commercially available ELISA kits

Serum resistin

Intervention Type DIAGNOSTIC_TEST

resistin concentrations will be assayed using commercially available ELISA kits

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Serum asymmetteric dimethyl arginine

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Serum vaspin

vaspin concentrations will be assayed using commercially available ELISA kits

Intervention Type DIAGNOSTIC_TEST

Serum resistin

resistin concentrations will be assayed using commercially available ELISA kits

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ADMA Lipids

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Tarek Mohamed Mostafa

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tarek M Mostafa, Ass. Prof.

Role: STUDY_DIRECTOR

Tanta University

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24929806 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24999311 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CP0002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MR and Inflammation After Preeclampsia
NCT07345845 ACTIVE_NOT_RECRUITING EARLY_PHASE1