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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT03398356
Eligibility Criteria:
Inclusion Criteria for treated groups ( A or B):
* age: 40-65 years;
* pre-diabetic status based on fasting plasma glucose (FPG) and / or OGTT;
* without metformin before;
* without ischemic heart disease in history;
* without a stroke in a history;
* without PAOD (peripheral arterial occlusive disease) in a history;
* without active cancer in a history
Exclusion Criteria for treated groups (A or B):
* age \<40 or \>65;
* diabetes;
* taking metformin before study;
* active cancer;
* history of macro-angiopathy (ischemic heart disease, stroke or TIA, PAOD);
* serious gastrointestinal disease that may affect metformin tolerance;
* renal failure with GFR\<45 ml/min/1.73m2;
* alanin transaminase \> 3 x ULN
Inclusion criteria for healthy volunteers:
* age: 40-65 years;
* no carbo-hydrates disturbances (based on fasting plasma glucose (FPG) and/or OGTT);
* without metformin before;
* without ischemic heart disease in history;
* without a stroke in a history;
* without PAOD (peripheral arterial occlusive disease) in a history;
* without active cancer in a history
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT03398356
Study Brief:
Protocol Section:
NCT03398356