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 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT03310359
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-75 years (inclusive)
* Both males and females
* If female, must be post-menopausal or not capable of becoming pregnant
* Able to give informed consent to the procedures
* Dyslipidemia - \[TG\]\>150, or \[LDL\]\>100 or \[HDL\]\<40 for males, \<50 for females or taking a statin or fibrate
* BMI = 25-39
* Impaired fasting glucose 95\>\[FG\]\<125 and/or elevated HbA1c (5.7-6.4%)
* Concomitant medication use stable for 30 days prior to screening visit (Acceptable medications: anti-hypertensive if blood pressure criteria met statins or fibrates)
Exclusion Criteria:
* Type 2 diabetes
* Type 1 diabetes
* Pregnant
* Younger than 18 or older than 75 years of age.
* Clinically significant abnormalities in liver (\> 3x ULN) or kidney function (eGFR \< 30)
* Myocardial Infarction (MI) (within 6 months of screening)
* Stroke (within 6 months of screening)
* Blood pressure (BP) \>160 mmHg Systolic and \>100 mmHg Diastolic
* The following medications are exclusionary: thiazolidinediones, any steroids, anti-depressants, weight loss, and OTC antioxidants (if taking OTC antioxidant supplements, subjects must be willing to stop taking them immediately upon site verifying that the subject qualifies for enrollment and for the duration of the entire study. Some OTC antioxidants may be acceptable upon approval by the Principal Investigator.)
* Other disease, besides type 2 diabetes, influencing carbohydrate metabolism.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03310359
Study Brief:
Protocol Section:
NCT03310359