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OpenTrials
Completed

NCT Number: NCT06336512

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

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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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

22 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Benha university

Banhā, El- Qalyobia, 13511, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ELISA

Diagnostic Test

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

Primary outcomes

  1. Estimation of Gestational DM

    Time frame: 8 months

    Relation between Serum Zonulin levels and Gestational Diabetes Mellitus

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2024
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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