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NCT Number: NCT07557329

Intestinal Endotoxemia and Beta- Cell Dysfunction in 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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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:

  • Compare endotoxemia levels (LBP) between lean prediabetic (HOMA-IR <1.5) and healthy controls.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hba1c, lbp, fasting blood sugar, lipogram, fastinf insulin

Diagnostic Test

diagnostic tests for prediabetes and intestinal endotoxemia

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

hanaa mohamed abdel azeem, specialist

CONTACT

[email protected]

+201061139402

mahmoud ahmed soliman, lecturer

CONTACT

[email protected]

+201098333296

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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