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Evaluation of Serum Pentraxin 3 and High Sensitive CRP in Female Patients With Gestational Diabetes Mellitus in Second Trimester of Pregnancy

Primary Purpose

Gestational Diabetes Mellitus in Second Trimester of Pregnancy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
serum pentraxin 3 and high sensitive CRP
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gestational Diabetes Mellitus in Second Trimester of Pregnancy focused on measuring serum pentraxin 3,high sensitive CRP in female patients with gestational diabetes mellitus

Eligibility Criteria

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Inclusion Criteria: Pregnant women. Diagnosed GDM. 3Gestational age >20weeks Exclusion Criteria: Women with pregestational diabetes . Women with chronic diseases. Twin pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    serum pentraxin 3 and high sensitive CRP

    Arm Description

    female with gestational diabetes mellitus in 2nd trimester

    Outcomes

    Primary Outcome Measures

    Mean different in concentration of serum pentraxin-3 and high sensitive CRP levels in study groups.
    female patients with gestational diabetes mellitus in second trimester of pregnancy

    Secondary Outcome Measures

    Full Information

    First Posted
    April 26, 2023
    Last Updated
    April 26, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05846191
    Brief Title
    Evaluation of Serum Pentraxin 3 and High Sensitive CRP in Female Patients With Gestational Diabetes Mellitus in Second Trimester of Pregnancy
    Official Title
    Evaluation of Serum Pentraxin 3 and High Sensitive CRP in Female Patients With Gestational Diabetes Mellitus in Second Trimester of Pregnancy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 5, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    March 10, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To assess the value of serum Pentraxin-3 and high sensitive CRP in females with normal pregnancy and females with gestational diabetes mellitus in second trimester of pregnancy. To study correlations between serum Pentraxin-3 and High sensitive CRP in gestational diabetes.
    Detailed Description
    Gestational diabetes mellitus (GDM) refers to abnormal glucose metabolism that occurs or is discovered during pregnancy, it can cause multiple poor outcomes and increase maternal and child prevalence and mortality. GDM can increase the risk of type 2 diabetes mellitus (T2DM) and cardiovascular diseases in pregnant women, and the risk of metabolic disorders in their offspring is high, so it's called a disease that affects two generations.(1) The relationship between maternal hyperglycemia and fetal macrosomia together with other complications has been confirmed.(2) Women with GDM have a higher long-term risk of type 2 diabetes mellitus.(3) Pentraxin 3 (PTX3) and high sensitive CRP are both the acute phase proteins belonging to the pentraxin family but with different biological characteristics, CRP belongs to the short PTX, which is an acute phase protein synthesized by the hepatocytes when the body is stimulated by microbial invasion or tissue damage.(4) PTX3 is a long-chain PTX protein. A variety of tissue cells can produce PTX3 under the stimulation of pro-inflammatory factors, including the endothelial cells, fibroblasts, monocytes, adipocytes, etc.(5,6) There is one study(Changes of serum pentraxin-3 and hypersensitive CRP levels during pregnancy and their relationship with gestational diabetes mellitus , 2019) , that has come to PTX3 and hs-CRP may be related to the pathogenesis of GDM, and they are significantly increased in the second trimester, which provides a new idea for early prevention and treatment of GDM .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gestational Diabetes Mellitus in Second Trimester of Pregnancy
    Keywords
    serum pentraxin 3,high sensitive CRP in female patients with gestational diabetes mellitus

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Evaluation of serum pentraxin 3 and high sensitive CRP in female patients with gestational diabetes mellitus in second trimester of pregnancy.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    serum pentraxin 3 and high sensitive CRP
    Arm Type
    Other
    Arm Description
    female with gestational diabetes mellitus in 2nd trimester
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    serum pentraxin 3 and high sensitive CRP
    Intervention Description
    serum pentraxin 3 and high sensitive CRP
    Primary Outcome Measure Information:
    Title
    Mean different in concentration of serum pentraxin-3 and high sensitive CRP levels in study groups.
    Description
    female patients with gestational diabetes mellitus in second trimester of pregnancy
    Time Frame
    2 years

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Pregnant women. Diagnosed GDM. 3Gestational age >20weeks Exclusion Criteria: Women with pregestational diabetes . Women with chronic diseases. Twin pregnancy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mai Mohammed Hosny
    Phone
    01017818070
    Email
    mai.7osny123@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hanan Galal Abd Alazim, professor
    Phone
    01062226610
    Email
    Hanangalal2000@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29288571
    Citation
    Zhao B, Han X, Meng Q, Luo Q. Early second trimester maternal serum markers in the prediction of gestational diabetes mellitus. J Diabetes Investig. 2018 Jul;9(4):967-974. doi: 10.1111/jdi.12798. Epub 2018 Jan 28.
    Results Reference
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    PubMed Identifier
    31086534
    Citation
    Dongel I, Gokmen AA, Gonen I, Kaya S. Pentraxin-3 and inflammatory biomarkers related to posterolateral thoracotomy in Thoracic Surgery. Pak J Med Sci. 2019 Mar-Apr;35(2):464-469. doi: 10.12669/pjms.35.2.181.
    Results Reference
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    Evaluation of Serum Pentraxin 3 and High Sensitive CRP in Female Patients With Gestational Diabetes Mellitus in Second Trimester of Pregnancy

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