Intestinal Endotoxemia and Beta- Cell Dysfunction in Prediabetics

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07557329

Enrollment

120

Registered

2026-04-29

Start date

2026-05-01

Completion date

2027-06-01

Last updated

2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetic State, Prediabetic State (IGT)

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

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_TESThba1c, lbp, fasting blood sugar, lipogram, fastinf insulin

diagnostic tests for prediabetes and intestinal endotoxemia

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Egypt

Contacts

CONTACThanaa mohamed abdel azeem, specialist

hanaaabdelazem161@gmail.com+201061139402

CONTACTmahmoud ahmed soliman, lecturer

solymanmahmoud87@yahoo.com+201098333296

STUDY_DIRECTORMahmoud A Soliman

Sohag University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026