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

Benha University

Status: Completed

Conditions: Gestational Diabetes

Treatments: Diagnostic Test: ELISA

Study type: Interventional

Funder types: Other

Identifiers

NCT06336512

RC.28.1.2024

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Female

Ages: 22 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

serum zonulin

Other group

Treatment:

Diagnostic Test: ELISA