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

NCT ID: NCT05846191

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-05

Study Completion Date

2025-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Diabetes Mellitus in Second Trimester of Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Evaluation of serum pentraxin 3 and high sensitive CRP in female patients with gestational diabetes mellitus in second trimester of pregnancy.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

serum pentraxin 3 and high sensitive CRP

female with gestational diabetes mellitus in 2nd trimester

Group Type OTHER

serum pentraxin 3 and high sensitive CRP

Intervention Type DIAGNOSTIC_TEST

serum pentraxin 3 and high sensitive CRP

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

serum pentraxin 3 and high sensitive CRP

serum pentraxin 3 and high sensitive CRP

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mai Mohammed Hosny

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mai Mohammed Hosny

Role: CONTACT

01017818070

Hanan Galal Abd Alazim, professor

Role: CONTACT

01062226610

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29288571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31086534 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Evaluation of S.pentraxin3&CRP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

GDM Post Partum Screening
NCT03946631 TERMINATED
Biomarkers During Pregnancy
NCT04108455 UNKNOWN