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

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-15

Study Completion Date

2023-10-01

Brief Summary

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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.

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Gestational Diabetes

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Detailed Description

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Conditions

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Gestational Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Newly Pregnant Women with singleton fetus

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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serum zonulin

Group Type OTHER

ELISA

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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ELISA

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes