Intestinal Endotoxemia and Beta- Cell Dysfunction in Prediabetics

April 29, 2026 updated by: Hanaa Mohammed Abdel Azeem, Sohag University

Association Between Intestinal Endotoxemia and Beta-Cell Dysfunction in Lean Prediabetics

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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 .

Description

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:

  • - 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1: cases
lean prediabetics
Diagnostic test: hba1c, lbp, fasting blood sugar, lipogram, fastinf insulin
diagnostic tests for prediabetes and intestinal endotoxemia
group 2:controls
healthy controls
Diagnostic test: hba1c, lbp, fasting blood sugar, lipogram, fastinf insulin
diagnostic tests for prediabetes and intestinal endotoxemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between intestinal endotoxemia (measured by serum LBP) and basal beta-cell dysfunction (HOMA-B) in lean prediabetic patients
Time Frame: one year
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).
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Director: Mahmoud A Soliman, Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med--26-4-2MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

to maintain patient confidentialty

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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