Intestinal Endotoxemia and Beta- Cell Dysfunction in Prediabetics
Association Between Intestinal Endotoxemia and Beta-Cell Dysfunction in Lean Prediabetics
1 other identifier
observational
120
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2026
CompletedFirst Posted
Study publicly available on registry
April 29, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
May 5, 2026
April 1, 2026
1 year
April 22, 2026
April 29, 2026
Conditions
Outcome Measures
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).
one year
Study Arms (2)
group 1: cases
lean prediabetics
group 2:controls
healthy controls
Interventions
diagnostic tests for prediabetes and intestinal endotoxemia
Eligibility Criteria
The patient population for the trial will be derived from Outpatient clinics, Sohag University Hospital 120 participants .
You may qualify if:
- 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%
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sohag Universitylead
Study Sites (1)
Sohag University
Sohag, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mahmoud A Soliman
Sohag University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- internal medicine specialist
Study Record Dates
First Submitted
April 22, 2026
First Posted
April 29, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
to maintain patient confidentialty