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

April 26, 2023 updated by: Mai Mohammed Hosny, Assiut University

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

  1. 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.
  2. To study correlations between serum Pentraxin-3 and High sensitive CRP in gestational diabetes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Pregnant women.
  2. Diagnosed GDM. 3Gestational age >20weeks

Exclusion Criteria:

  1. Women with pregestational diabetes .
  2. Women with chronic diseases.
  3. Twin pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: serum pentraxin 3 and high sensitive CRP
female with gestational diabetes mellitus in 2nd trimester
Diagnostic test: serum pentraxin 3 and high sensitive CRP
serum pentraxin 3 and high sensitive CRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean different in concentration of serum pentraxin-3 and high sensitive CRP levels in study groups.
Time Frame: 2 years
female patients with gestational diabetes mellitus in second trimester of pregnancy
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 5, 2023

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

March 10, 2025

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Estimate)

May 5, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Evaluation of S.pentraxin3&CRP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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