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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06336512
Enrollment
70
Registered
2024-03-28
Start date
2023-01-15
Completion date
2023-10-01
Last updated
2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Brief 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.

Interventions

DIAGNOSTIC_TESTELISA

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

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Newly Pregnant Women with singleton fetus

Eligibility

Sex/Gender
FEMALE
Age
22 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Estimation of Gestational DM8 monthsRelation between Serum Zonulin levels and Gestational Diabetes Mellitus

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026