Intestinal Endotoxemia and Beta- Cell Dysfunction in Prediabetics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: hba1c, lbp, fasting blood sugar, lipogram, fastinf insulin.
- Who it may be relevant to
- Registry conditions: Prediabetic State (IGT), Prediabetic State. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Association Between Intestinal Endotoxemia and Beta-Cell Dysfunction in Lean Prediabetics
Overview
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
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.
Interventions
- Diagnostic test hba1c, lbp, fasting blood sugar, lipogram, fastinf insulin
diagnostic tests for prediabetes and intestinal endotoxemia
Primary outcome measures
- correlation between intestinal endotoxemia (measured by serum LBP) and basal beta-cell dysfunction (HOMA-B) in lean prediabetic patients [Time frame: one year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Egypt · 1 center
- Sohag University — Sohag
Identifiers
NCT: NCT07557329 · Soh-Med--26-4-2MD