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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT03558867
Eligibility Criteria:
Inclusion criteria:
* Individuals with pre-diabetes or newly-diagnosed (in the last 6 months) with type 2 diabetes, fulfilling the following criteria:
* Impaired fasting glucose (IFG, plasma glucose \[PG\]- 5.6 - 6.9 mmol/L, ±0.2 mmol/L) and/or impaired glucose tolerance (IGT, 2-h PG 7.8 - 11.0 mmol/L, ±0.2 mmol/L) with or without elevated HbA1c (up to 8.0 %).
* Willingness to provide written informed consent and willingness to participate and comply with the study.
Exclusion Criteria:
* Females planning a pregnancy during the course of the research or 3 months after completion of the research project.
* Patients with type 1 diabetes, chronically active inflammatory disease, neoplastic disease in the previous 3 years, chronic gastrointestinal disorders, including inflammatory bowel disease or celiac.
* Liver enzymes ALT and/or AST\>3-times normal range limit.
* Abnormal renal function as measured by (eGFR\<45 mL/min/1.73m\^2).
* Individuals with a history of a psychological illness or condition that may interfere with the individual's ability to understand the requirements of the study.
* Normo-glycaemia.
* HbA1c\>8.0%
* Cardiovascular event in the previous 6 months.
* Current or recent (within 24 months) treatment with a glucose lowering medication (i.e. GLP-1 receptor agonist, SGLT2 inhibitor, thiazolidinedione, sulfonylurea, DPP-4 inhibitor or insulin).
* Current or recent (within 3 months) treatment with metformin.
* Treatment with an oral steroid.
* Treatment with antibiotics/antifungal in the last 3 month.
* Treatment with immunosuppressive medications.
* Alcohol or substance abuse.
* Participants who had received an investigational new drug within the last 6 months.
* Participants involved in another clinical study.
* Participants who actively lose weight.
* Participants who had a bariatric surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT03558867
Study Brief:
Protocol Section:
NCT03558867