<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04455204</url>
  </required_header>
  <id_info>
    <org_study_id>CP0002</org_study_id>
    <nct_id>NCT04455204</nct_id>
  </id_info>
  <brief_title>Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in Preeclampsia</brief_title>
  <official_title>Implication of Adipokines, Inflammation, Insulin Resistance and Endothelial Dysfunction in the Pathogenesis of Preeclampsia and in Pregnancy Related Complications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to evaluate the implication of adipokines, inflammation,&#xD;
      insulin resistance and endothelial dysfunction in the pathogenesis of preeclampsia and in&#xD;
      pregnancy related complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This observational parallel study will be conducted on pregnant women with normal pregnancy,&#xD;
      pregnant women with Preeclampsia, and on healthy non-pregnant women. All participants will be&#xD;
      recruited from the Outpatient Clinic of Obstetrics and Gynecology Department at Menoufia&#xD;
      University Hospital (Shebin El-Kom, Egypt). The study will be approved by the Research Ethics&#xD;
      Committee of Menoufia University and all the involved subjects will give their written&#xD;
      informed consent.&#xD;
&#xD;
      This study will involve a total number of 60 women who will be further classified into: 20&#xD;
      non-pregnant women who serve as the control group (group 1), 20 pregnant women with normal&#xD;
      pregnancy at their third trimesters (group 2) and 20 pregnant women with Preeclampsia at&#xD;
      their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria.&#xD;
      The pregnant women will be assessed in their third trimesters and further re-evaluated 4&#xD;
      weeks after delivery. The gestational ages will be determined conventionally and re-affirmed&#xD;
      by ultrasonographic measurement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2016</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Interleukin 18</measure>
    <time_frame>Nine months</time_frame>
    <description>IL-18 will be carried out using Enzyme-Linked Immunosorbent Assay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vaspin level</measure>
    <time_frame>Nine months</time_frame>
    <description>Serum vaspin concentrations will be assayed using commercially available ELISA kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>resistin level</measure>
    <time_frame>Nine months</time_frame>
    <description>Serum resistin concentrations will be assayed using commercially available ELISA kits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Malondialdehyde level</measure>
    <time_frame>Nine Months</time_frame>
    <description>MDA will be measured spectrophotometrically</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum asymmetteric dimethyl arginine (ADMA)</measure>
    <time_frame>Nine Months</time_frame>
    <description>Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>insulin resistance (IR)</measure>
    <time_frame>Nine Months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Pre-Eclampsia</condition>
  <arm_group>
    <arm_group_label>non-pregnant women (group 1)</arm_group_label>
    <description>20 non-pregnant women who serve as a control group (group 1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pregnant women (group 2)</arm_group_label>
    <description>20 pregnant women with normal pregnancy at their third trimesters (group 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pregnant women with Preeclampsia (group 3)</arm_group_label>
    <description>20 pregnant women with Preeclampsia in their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serum asymmetteric dimethyl arginine</intervention_name>
    <description>Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay</description>
    <arm_group_label>non-pregnant women (group 1)</arm_group_label>
    <arm_group_label>pregnant women (group 2)</arm_group_label>
    <arm_group_label>pregnant women with Preeclampsia (group 3)</arm_group_label>
    <other_name>ADMA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>serum lipid profiles</intervention_name>
    <description>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</description>
    <arm_group_label>non-pregnant women (group 1)</arm_group_label>
    <arm_group_label>pregnant women (group 2)</arm_group_label>
    <arm_group_label>pregnant women with Preeclampsia (group 3)</arm_group_label>
    <other_name>Lipids</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serum vaspin</intervention_name>
    <description>vaspin concentrations will be assayed using commercially available ELISA kits</description>
    <arm_group_label>non-pregnant women (group 1)</arm_group_label>
    <arm_group_label>pregnant women (group 2)</arm_group_label>
    <arm_group_label>pregnant women with Preeclampsia (group 3)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serum resistin</intervention_name>
    <description>resistin concentrations will be assayed using commercially available ELISA kits</description>
    <arm_group_label>non-pregnant women (group 1)</arm_group_label>
    <arm_group_label>pregnant women (group 2)</arm_group_label>
    <arm_group_label>pregnant women with Preeclampsia (group 3)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        total number of 60 women who will be further classified into: 20 non-pregnant women who&#xD;
        serve as control group (group 1), 20 pregnant women with normal pregnancy at their third&#xD;
        trimesters (group 2) and 20 pregnant women with Preeclampsia at their third trimester&#xD;
        (group 3) will be screened to fit the inclusion and exclusion criteria. The pregnant women&#xD;
        will be assessed in their third trimesters and further re-evaluated 4 weeks after delivery.&#xD;
        The gestational ages will be determined conventionally and re-affirmed by ultrasonographic&#xD;
        measurement.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women with normal pregnancy (n=20)&#xD;
&#xD;
          -  Pregnant women with Preeclampsia (n=20) at their third trimesters of pregnancy will be&#xD;
             included in the study. Preeclampsia will be defined and diagnosed by constant&#xD;
             elevation in blood pressure greater than 140/90 mmHg and by the presence of&#xD;
             proteinuria above 300 mg /24 hour with the absence of both urinary tract infection and&#xD;
             previous history of hypertension.&#xD;
&#xD;
          -  Apparently healthy non-pregnant females (n=20) will be included in this study also.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with risk factors for oxidative stress such as smokers and&#xD;
&#xD;
          -  Those with a medical history of diabetes mellitus (DM) and Tuberculosis (T.B).&#xD;
&#xD;
          -  Women with a history of hypertension, familial hyperlipidemia, liver diseases,&#xD;
             inflammatory diseases, and renal impairment.&#xD;
&#xD;
          -  Non-pregnant women on hormonal therapy or hormonal contraceptives.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Tarek M Mostafa, Ass. Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Tanta University</affiliation>
  </overall_official>
  <reference>
    <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>
    <PMID>24929806</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24999311</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Dr. Tarek Mohamed Mostafa</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04455204
org study id: CP0002
nct id: NCT04455204
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Interleukin 18
time frame: Nine months
description: IL-18 will be carried out using Enzyme-Linked Immunosorbent Assay
measure: Vaspin level
time frame: Nine months
description: Serum vaspin concentrations will be assayed using commercially available ELISA kits
measure: resistin level
time frame: Nine months
description: Serum resistin concentrations will be assayed using commercially available ELISA kits
measure: Malondialdehyde level
time frame: Nine Months
description: MDA will be measured spectrophotometrically
measure: Serum asymmetteric dimethyl arginine (ADMA)
time frame: Nine Months
description: Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay
measure: insulin resistance (IR)
time frame: Nine Months
description: 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).
arm group label: non-pregnant women (group 1)
description: 20 non-pregnant women who serve as a control group (group 1)
arm group label: pregnant women (group 2)
description: 20 pregnant women with normal pregnancy at their third trimesters (group 2)
arm group label: pregnant women with Preeclampsia (group 3)
description: 20 pregnant women with Preeclampsia in their third trimester (group 3) will be screened to fit the inclusion and exclusion criteria.
intervention type: Diagnostic Test
intervention name: Serum asymmetteric dimethyl arginine
description: Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay
arm group label: non-pregnant women (group 1)
arm group label: pregnant women (group 2)
arm group label: pregnant women with Preeclampsia (group 3)
other name: ADMA
intervention type: Diagnostic Test
intervention name: serum lipid profiles
description: 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
arm group label: non-pregnant women (group 1)
arm group label: pregnant women (group 2)
arm group label: pregnant women with Preeclampsia (group 3)
other name: Lipids
intervention type: Diagnostic Test
intervention name: Serum vaspin
description: vaspin concentrations will be assayed using commercially available ELISA kits
arm group label: non-pregnant women (group 1)
arm group label: pregnant women (group 2)
arm group label: pregnant women with Preeclampsia (group 3)
intervention type: Diagnostic Test
intervention name: Serum resistin
description: resistin concentrations will be assayed using commercially available ELISA kits
arm group label: non-pregnant women (group 1)
arm group label: pregnant women (group 2)
arm group label: pregnant women with Preeclampsia (group 3)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 35 Years
last name: Tarek M Mostafa, Ass. Prof.
role: Study Director
affiliation: Tanta University
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.
PMID: 24929806
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.
PMID: 24999311
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Dr. Tarek Mohamed Mostafa
investigator title: Associate Professor
mesh term: Pre-Eclampsia
mesh term: Eclampsia
mesh term: Insulin Resistance
mesh term: Inflammation
sharing ipd: No