Clinical trial NCT05846191: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus in Second Trimester of Pregnancy
Keywords: serum pentraxin 3,high sensitive CRP in female patients with gestational diabetes mellitus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Evaluation of serum pentraxin 3 and high sensitive CRP in female patients with gestational diabetes mellitus in second trimester of pregnancy.
Primary purpose: OTHER

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.

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Mean different in concentration of serum pentraxin-3 and high sensitive CRP levels in study groups.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
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.