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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT03109067
Eligibility Criteria:
Inclusion Criteria:
1. Affiliation to a national social security scheme
2. Age between 18 and 60 years old
3. Male subjects
4. Participants harboring either a B2 (genotype AA) allele or a B1 (genotype GG) in TaqIB polymorphism of CETP gene
5. Fasted plasmatic triglyceridemia \< 300 mg/dL
6. Free prior and informed written consent given by the participant
Exclusion Criteria:
1. Participants with an history of symptomatic cardio-vascular disease (infarct, angina pectoris, acute coronary syndrome, cardiac surgery, endoluminal coronal intervention, stroke, symptomatic peripheral artery disease) within 6 months prior to inclusion.
2. Triglyceridemia \> 3 g/L
3. Participants having other lipid-lowering agents than statin (fibrate, niacin, ezetimibe)
4. Participants having a treatment (either systemic or local) which might interfere with the evaluation of study parameters.
5. Excessive alcohol consumption, or any drug addiction. An excessive alcohol consumption is superior to 21 time 30 mL of alcohol or 120 mL of wine or 355 mL of beer.
6. Regular smoker or smoking cessation within the last year
7. Significant abnormality on the full blood count or plasmatic and urinary biochemistry analysis.
8. Chronic or acute disease either life threatening or able to modify study results, including among others :
1. Diabetes
2. Renal diseases : nephrotic syndrome, chronic kidney failure and/or creatininemia \> 1.7 time the upper limit of normal (ULN).
3. Hypothyroidism defined by thyroid-stimulating hormone \> 2x ULN
4. Hepatobiliary disease or viral hepatitis B or C confirmed by transaminases \> 2x ULN or alkaline phosphatase \> 1.5x ULN or total bilirubinemia \> 1.5x ULN at screening.
5. Known HIV
6. Gastro-intestinal disorder or disease that might modify intestinal absorption, bariatric surgery.
9. Participant who might interfere with the quality of the study or might compromise the study according to the investigator.
10. Participant currently enrolled in another study or in the exclusion period of another study.
11. Participants with uncontrolled hypertension defined by a systolic blood pressure \> 140 mmHg or a diastolic blood pressure \> 90 mmHg.
12. Participants with a C reactive protein (CRP) \> 5mg/L
13. Participants with a E2/E2 phenotype of apolipoprotein E.
14. Blood donation or product derived-from blood donation within the last 3 months prior to the test meal.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03109067
Study Brief:
Protocol Section:
NCT03109067