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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT02346669
Eligibility Criteria:
Inclusion Criteria:
* 30≤BMI
* A diagnosis of T2DM (≥3 months) and one of the following:
1. Fasting glucose level≥126mg/dL and/ or
2. A stable dose of anti-diabetic drugs for ≥2 weeks and/or
3. HbA1C≥6.5
* Access to a smart phone supporting the research application for tracking food consumption.
Exclusion Criteria:
* participation in other clinical trial
* incapable of signing an informed consent
* pregnancy or breast feeding
* Antibiotic treatment within the prior 3 months or predicted antibiotic treatment
* insulin medications
* drugs or alcohol addiction
* immune mediated diseases
* type 1 diabetes and latent autoimmune diabetes of adults
* systemic disease
* ischemic heart disease
* probiotics consumption
* a new or unstable treatment with anti diabetic medications
Patients will also be excluded if:
* treated by systemic antibiotic during the study
* will not be compliant with the diet
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02346669
Study Brief:
Protocol Section:
NCT02346669