Trimester Sequential Estimation of Serum Zonulin as a Predictor of Gestational Diabetes Mellitus

Gestational Diabetes Clinical Trial

Official title:

Trimester Sequential Estimation of Serum Zonulin Overrides Glucose Homeostasis Biomarkers for Prediction of Gestational Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06336512
• Other study ID #: RC.28.1.2024
• Status: Completed
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: March 2024
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gestational diabetes mellitus (GDM) is the development of glucose intolerance (GI) during pregnancy in a previously normoglycemic (NG) woman and associated with insulin resistance (IR). GDM is the most prevalent metabolic disorder during pregnancy and became a major public health problem for being usually diagnosed and detected after 24 gestational weeks (GW), while its complications can occur much earlier and this may explain its burden on maternal and fetal welfare. Human zonulin is a surrogate marker of intestinal permeability and can be utilized as biomarker for intestinal barrier function. Zonulin-mediated increase in intestinal permeability plays a role in the pathogenesis of insulin resistance, obesity, DM and metabolic syndrome. The increasing global prevalence of GDM with its associated risk of poor pregnancy and long-term risks for the mother and the offspring may lead to the production of new generation of diabetics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnant Women with singleton fetus

Exclusion Criteria:

• Women with morbid obesity with body mass index =35 kg/m2;
• Had manifest DM, irrespective of being controlled or not;
• Bowel-related disorders;
• Autoimmune disorders;
• History of previous GDM.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Diagnostic Test:
• ELISA
Estimation of Zonulin by ELISA from the Blood samples which were obtained at time of pregnancy .

Locations

Country	Name	City	State
Egypt	Benha university	Banha	El- Qalyobia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of Gestational DM	Relation between Serum Zonulin levels and Gestational Diabetes Mellitus	8 months