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:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT03434860
Eligibility Criteria:
Inclusion Criteria:
* adult participants (ages 18-75, BMI ≥25 kg/m2) diagnosed with T2D according WHO (1999) for at least 6 months prior to the study;
* patient who treated with diet and exercise alone or metformin, SUs and insulin on a stabilized dose for at least 3 months before the study;
* presence of insulin resistance established as HOMA-IR≥2.0;
* HbA1c between 6.5 and 11.0 %;
* written informed consent.
Exclusion Criteria:
* presence of type 1 diabetes;
* treatment with other than mention in inclusion criteria antidiabetic drugs (pioglitazone, GLP-1 analogues, DPP IV inhibitors etc);
* regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment;
* antibiotic use within 3 months prior to enrollment;
* uncontrolled cardiovascular or respiratory disease, decompensated liver disease including ascites, encephalopathy or variceal bleeding, active malignancy, or chronic infections;
* participation in other clinical trials;
* presence of pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03434860
Study Brief:
Protocol Section:
NCT03434860