CClinicalTrials.gg
CompletedNCT06336512Updated Mar 28, 2024

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

An interventional study of ELISA in Gestational Diabetes, sponsored by Benha University. Completed at 1 site in Egypt. Open to female participants aged 22 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by Benha University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2023, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
22 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Gestational Diabetes
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 70 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Pregnant Women with singleton fetus

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Other
    serum zonulin

    Diagnostic Test: ELISA

Interventions

  • Diagnostic testELISA

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

06

What researchers measure

Primary outcomes

  1. Estimation of Gestational DM

    Relation between Serum Zonulin levels and Gestational Diabetes Mellitus

    Time frame: 8 months

07

Study locations

1 site
  • Benha university
    Banhā, El- Qalyobia 13511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06336512
Lead sponsor
Benha University
Responsible party
Ahmed K Zaineldin (Lecturer of Obstetrics & Gynecology, Faculty of Medicine, Benha University) — Principal investigator
First posted
Mar 28, 2024
Start date
Jan 15, 2023
Primary completion
Jul 1, 2023
Completion
Oct 1, 2023
Last update
Mar 28, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion