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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT06526494
Eligibility Criteria:
Inclusion Criteria:
* Age 18-55 years
* Prediabetes defined as an HbA1c between 5.7% and 6.4%
* Able to provide informed consent
Exclusion Criteria:
* Current use of metformin or metformin use within the past 12 months
* Current use of medicated contraindicated for use with metformin
* Current use of vitamin C supplement
* Current smoker or quit smoking within the last 6 months
* Pregnant, breastfeeding, planning to become pregnant, or unwilling to use adequate birth control
* Uncontrolled hypertension (Systolic blood pressure \>140 mmHg)
* Body Mass Index \> 40 kg/m2
* History of diabetes, myocardial infarction, heart failure, liver disease, or chronic kidney disease (estimated glomerular filtration rate \< 45 ml/min/1.73m2)
* History of lactic acidosis
* History of alcohol abuse
* Severe infection within the last 30 days
* Immunosuppressive therapy within the past year
* Life expectancy \< 1 year
* Allergy to metformin, nitroglycerin, sodium nitroprusside, ringer's lactate
* Study compliance: Unwilling to fast overnight, have an intravenous catheter placed, take a study drug for 12 weeks, or visit Iowa campus 6 times within a 12-16 week period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06526494
Study Brief:
Protocol Section:
NCT06526494