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 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT02656095
Eligibility Criteria:
Inclusion Criteria:
1\. male and females between ages of 20-39
Exclusion Criteria:
1. Past history of LPL deficiency
2. Hypercholesterolemia (Cholesterol \>200, LDL \>160, HDL \<35) hypertriglyceridemia (TG\>150), any familial lipid disorder
3. Diabetes mellitus (type 1 or 2)
4. Uncontrolled hypertension SBP\>140, DBP\>90
5. History of hemorrhagic stroke
6. Current pregnancy
7. History of major surgery, invasive procedure or trauma within the last 30 days, or planned major surgery within 30 days after participating in the study
8. Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 30 days prior to screening
9. History of allergy to heparin
10. History of heparin-induced thrombocytopenia
11. Current smoking
12. Active ulcerative or angiodysplastic GI diseases
13. Thrombocytopenia or platelet disorders (Platelet count \<100,000/UL)
14. Major health issues which may affect the safety of study subject, including but not limited to:
* History of chronic kidney disease (eGFR\<60)
* Long term use of medications which alter lipid metabolism
* History of hepatic disease (ALT or AST more than 2 times the upper limit of normal)
* History of clotting disorders, any type of coagulation factor deficiency, or thrombocytopenia
* Chronic use of ASA, anticoagulants, platelet inhibitors
* Use of NSAIDS for more than 2 weeks prior to screening
* Anemia (hemoglobin \<13 g/dL)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
39 Years
Study:
NCT02656095
Study Brief:
Protocol Section:
NCT02656095