Pre-Eclampsia Clinical Trial
Official title:
Implication of Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in the Pathogenesis of Preeclampsia and in Pregnancy Related Complications
NCT number | NCT04455204 |
Other study ID # | CP0002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 25, 2016 |
Est. completion date | October 1, 2019 |
Verified date | July 2020 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 1, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 25 Years to 35 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Interleukin 18 | IL-18 will be carried out using Enzyme-Linked Immunosorbent Assay | Nine months | |
Primary | Vaspin level | Serum vaspin concentrations will be assayed using commercially available ELISA kits | Nine months | |
Primary | resistin level | Serum resistin concentrations will be assayed using commercially available ELISA kits | Nine months | |
Primary | Malondialdehyde level | MDA will be measured spectrophotometrically | Nine Months | |
Primary | Serum asymmetteric dimethyl arginine (ADMA) | Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay | Nine Months | |
Primary | 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 |
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