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
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
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
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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