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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05846191
Collaborator
(none)
90
1
15.1

Study Details

Study Description

Brief Summary

  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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: serum pentraxin 3 and high sensitive CRP
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Evaluation of serum pentraxin 3 and high sensitive CRP in female patients with gestational diabetes mellitus in second trimester of pregnancy.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)
Primary Purpose:
Other
Official Title:
Evaluation of Serum Pentraxin 3 and High Sensitive CRP in Female Patients With Gestational Diabetes Mellitus in Second Trimester of Pregnancy.
Anticipated Study Start Date :
Dec 5, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Mar 10, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Mean different in concentration of serum pentraxin-3 and high sensitive CRP levels in study groups. [2 years]

    female patients with gestational diabetes mellitus in second trimester of pregnancy

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mai Mohammed Hosny, Resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05846191
Other Study ID Numbers:
  • Evaluation of S.pentraxin3&CRP
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mai Mohammed Hosny, Resident doctor, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023