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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT01681693
Eligibility Criteria:
Inclusion Criteria:
* Subjects self-identify racial background, identify themselves, parents and four grandparents as African American
* Subject status is healthy volunteer from t In the event that diabetes is indicated in a normal subject based on OGTT results, we will notify the patients' primary care physician. he SOPHIE cohort OR diagnosis of T2DM based on American Diabetes Association (ADA) criteria
* Subjects over 18 years old and below 60 years
* Subjects who are healthy on the basis of medical history, physical examinations and laboratory tests if healthy volunteer from SOPHIE
* Subjects who agree with the written informed consent to participate in the study
Exclusion Criteria:
* Unable to confirm African-American ethnicity
* Under 18 years old
* Pregnant or lactating women (female subjects will have a urine pregnancy test at the screening visit).
* Prior history of any allergic reaction to metformin
* Has a risk of congestive heart failure requiring pharmacologic treatment (medical history)
* Has a prior history of renal\* or hepatic dysfunction (renal and hepatic function will be evaluated based on screening blood tests conducted prior to study enrollment)
* Risk of urinary or gastric retention or narrow-angle glaucoma (by medical history examination)
* Impaired renal function (e.g as suggested by abnormal creatinine clearance, eGFR \<60 or serum creatinine \>1.4 mg/dl in females and \>1.5 mg/dl in males) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction (heart attack), and septicemia, abnormal heart rhythms (tachyarrhythmias; heart beat \> 100 beats per minute).
* Impaired hepatic function (\> 1.5 times the upper limit of normal)
* Evidence of anemia (hemoglobin \<10 g)
* Taking a medication that could confound study results, such as known substrates or inhibitors of OCT3 and MATE1, such as cimetidine.
* They do not provide consent to participate in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01681693
Study Brief:
Protocol Section:
NCT01681693