Prediabetic State (IGT)NCT07557329
Intestinal Endotoxemia and Beta- Cell Dysfunction in Prediabetics
An observational study of Prediabetic State (IGT) and Prediabetic State, run by Sohag University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetic State (IGT), Prediabetic State
- What is being tested?
- hba1c, lbp, fasting blood sugar, lipogram, fastinf insulin
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- May 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patient population for the trial will be derived from Outpatient clinics, Sohag University Hospital 120 participants .
Who may be able to join
- 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)
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University
Sohag
Mahmoud Soliman, 01098333296, solymanmahmoud87@yahoo.com
About this study
Official title: 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
Read the 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:
- 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.
- Conditions
- Prediabetic State (IGT), Prediabetic State
- Being tested
- hba1c, lbp, fasting blood sugar, lipogram, fastinf insulin
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hba1c, lbp, fasting blood sugar, lipogram, fastinf insulinDiagnostic test
diagnostic tests for prediabetes and intestinal endotoxemia
| Study group | Role | What they receive |
|---|---|---|
| group 1: cases | lean prediabetics Receives: Diagnostic Test: hba1c, lbp, fasting blood sugar, lipogram, fastinf insulin | |
| group 2:controls | healthy controls Receives: Diagnostic Test: hba1c, lbp, fasting blood sugar, lipogram, fastinf insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic State (IGT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Mohammed Abdel Azeem, Sohag University
- Investigators
- Mahmoud A Soliman, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557329
- Sponsor's protocol ID
- Soh-Med--26-4-2MD
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to maintain patient confidentialty
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Intestinal Endotoxemia and Beta-Cell Dysfunction in Lean Prediabetics
- ClinicalTrials.gov ID
- NCT07557329
- Acronym / sponsor ID
- Soh-Med--26-4-2MD
- Conditions
- Prediabetic State (IGT), Prediabetic State
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1: cases | – | Diagnostic Test: hba1c, lbp, fasting blood sugar, lipogram, fastinf insulinlean prediabetics |
| group 2:controls | – | Diagnostic Test: hba1c, lbp, fasting blood sugar, lipogram, fastinf insulinhealthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population for the trial will be derived from Outpatient clinics, Sohag University Hospital 120 participants .
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hba1c, lbp, fasting blood sugar, lipogram, fastinf insulindiagnostic tests for prediabetes and intestinal endotoxemia | Diagnostic test | group 1: cases, group 2:controls |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No. to maintain patient confidentialty
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Prediabetic State (IGT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahmoud A Soliman study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prediabetic State (IGT) and Prediabetic State, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hanaa mohamed abdel azeem, specialist (+201061139402, hanaaabdelazem161@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between intestinal endotoxemia (measured by serum LBP) and basal beta-cell dysfunction (HOMA-B) in lean prediabetic patients (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.