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Not yet recruitingNCT07557329Updated May 5, 2026

Intestinal Endotoxemia and Beta- Cell Dysfunction in Prediabetics

An observational study in Prediabetic State (IGT) and Prediabetic State, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 65 Years
Sex
All
01

Study summary

the goal of this observation study is to learn about association between intestinal endotoxemia and prediabetes lean patients with the aim of prevention of diabetes in those category of patients

Read the detailed description

Primary Objective : To determine the correlation between intestinal endotoxemia (measured by serum LBP) and basal beta-cell dysfunction (HOMA-B) in lean prediabetic patients with minimal insulin resistance (HOMA-IR \<1.5).

Secondary Objectives:

  1. Compare endotoxemia levels (LBP) between lean prediabetic (HOMA-IR \<1.5) and healthy controls.
  2. Evaluate LBP's association with fasting glucose and insulin in beta-cell dysfunction phenotype.

Hypothesis:

In lean prediabetes with beta-cell dysfunction (HOMA-IR \<1.5), serum LBP levels correlate significantly with HOMA-B, indicating endotoxemia-driven beta-cell impairment.

02

Conditions studied

  • Prediabetic State (IGT)
  • Prediabetic State

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03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's planned enrollment of 120 is below the median of 216 across 128 observational studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The patient population for the trial will be derived from Outpatient clinics, Sohag University Hospital 120 participants .

Inclusion criteria

  • Age: 18-65 years
  • BMI: 18.5-24.9 kg/m²
  • ADA prediabetes: FPG 100-125 mg/dL OR 2hPG 140-199 mg/dL OR HbA1c 5.7-6.4%
  • HOMA-IR \<1.5 (key inclusion criterion)

Exclusion criteria

Exclusion Criteria:

  • - HOMA-IR ≥1.5
  • BMI ≥25 kg/m²
  • Diabetes, acute inflammation, GI disorders (Table 1) Group II (Controls): Lean normoglycemic ; age and sex-matched healthy subjects
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • group 1: cases

    lean prediabetics

    Diagnostic Test: hba1c, lbp, fasting blood sugar, lipogram, fastinf insulin

  • group 2:controls

    healthy controls

    Diagnostic Test: hba1c, lbp, fasting blood sugar, lipogram, fastinf insulin

Interventions

  • Diagnostic testhba1c, lbp, fasting blood sugar, lipogram, fastinf insulin

    diagnostic tests for prediabetes and intestinal endotoxemia

06

What researchers measure

Primary outcomes

  1. correlation between intestinal endotoxemia (measured by serum LBP) and basal beta-cell dysfunction (HOMA-B) in lean prediabetic patients

    To determine the correlation between intestinal endotoxemia (measured by serum LBP) and basal beta-cell dysfunction (HOMA-B) in lean prediabetic patients with minimal insulin resistance (HOMA-IR \<1.5).

    Time frame: one year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — to maintain patient confidentialty

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07557329
Lead sponsor
Sohag University
Responsible party
Hanaa Mohammed Abdel Azeem (internal medicine specialist, Sohag University) — Principal investigator
First posted
Apr 29, 2026
Start date
May 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
May 5, 2026

Study contacts

hanaa mohamed abdel azeem, specialist
Contact
hanaaabdelazem161@gmail.com
+201061139402
mahmoud ahmed soliman, lecturer
Contact
solymanmahmoud87@yahoo.com
+201098333296
Mahmoud A Soliman
study director · Sohag University

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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