Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT05854251
Eligibility Criteria:
Inclusion Criteria:
* Subjects with prediabetes defined by HbA1c 5.7-6.4 % or fasting plasma glucose 6.1-6.9 mmol/l or plasma glucose 2 h following 75g glucose ingestion of 7.8-11.0 mmol/l.
* BMI ≥ 28 kg/m2
* Age ≥ 18 years
* C-reactive protein ≥ 2 mg/dl
* For subjects with reproductive potential, willingness to use contraceptive measures adequate to prevent the subject from becoming pregnant during the study
Exclusion Criteria:
* Upper gastrointestinal surgery
* Diagnosis of any type of diabetes mellitus
* Signs of current infection
* Use of any glucose lowering medication within the last three months
* Use of investigational drug up to one week prior to start of treatment phase.
* Anti-inflammatory medication, including systemic glucocorticoid therapy.
* Neutropenia (leukocyte count \< 1.5 × 109/L or absolute neutrophil count (ANC) \< 0.5 × 109/L)
* Anemia (hemoglobin \< 11 g/dL for males, \< 10 g/dL for females)
* Clinically significant kidney or liver disease (creatinine \> 1.5 mg/dL, aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \> 2 × ULN, alkaline phosphatase \> 2 × ULN, or total bilirubin \[tBili\] \> 1.5 × ULN)
* Uncontrolled disease
* Currently pregnant or breastfeeding
* No subjects meeting the criteria for vulnerability. Participation in another study with investigational drug within the 30 days preceding and during the present study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05854251
Study Brief:
Protocol Section:
NCT05854251