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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT05743868
Eligibility Criteria:
Inclusion Criteria:
* Ability to give informed consent
* Overweight, defined as BMI 25-30 kg/m2
* Modest hypertriglyceridemia, defined as fasting plasma triglycerides 1.5-3.0mM
* High risk of insulin resistance, defined as fasting plasma insulin \>64pM
* Stable weight for at least 3mo prior to participation
Exclusion Criteria:
* Active or chronic liver disease, kidney disease, congestive heart failure, unstable angina, history of acute cardiovascular events within 6mo of screening, history of seizures or syncope, or an active infection requiring antimicrobial therapy;
* Use of insulin, thiazolidinediones, SGLT2 inhibitors, or sulfonylureas;
* Use of fibrates, omega 3 (fish oil), niacin, or PCSK9 antagonists;
* Use of systemic glucocorticoids within 60d prior to participation;
* Hematocrit \<35%;
* Pregnancy of breastfeeding;
* Active tobacco use, excessive alcohol intake (\>14U/wk), or history of drug abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05743868
Study Brief:
Protocol Section:
NCT05743868