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

NCT06336512 | Completed

• 1 other identifier: RC.28.1.2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Estimation of Gestational DM

  Relation between Serum Zonulin levels and Gestational Diabetes Mellitus

  8 months

Study Arms (1)

serum zonulin

OTHER

Diagnostic Test: ELISA

Interventions

ELISA DIAGNOSTIC_TEST

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

serum zonulin

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant Women with singleton fetus

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university

Banhā, El- Qalyobia, 13511, Egypt

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics & Gynecology, Faculty of Medicine

Model Details: Newly Pregnant Women with singleton fetus

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: January 15, 2023
• Primary Completion: July 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

EG (1)