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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT03038750
Eligibility Criteria:
Inclusion Criteria:
* Volunteers are homozygous for:
* Arm 1: The A-allele of rs6841581, they are assigned to the 'case' group. If they are homozygous for the G-allele, they are assigned to the 'control' group
* Arm 2: The G-allele of rs738409, they are assigned to the 'case' group. If they are homozygous for the C-allele, they are assigned to the 'control' group
* Arm 3: The G-allele of rs867186, they are assigned to the 'case' group. If they are homozygous for the A-allele, they are assigned to the 'control' group
* Volunteers are aged between 18-50 years old
* Volunteers have a BMI:
* Arm 1: Between18.5-29.9
* Arm 2: Between 25.0-39.9
* Arm 3: Between 18.5-29.9
* Volunteers are willing not to consume products containing alcohol or caffeine 12 hours prior to procedures. Additionally, volunteers must agree to fast before procedures for:
* Arm 1: At least 4 hours
* Arm 2: At least 8 hours (for visit 2 only)
* Arm 3: At least 4 hours
* Have given written informed consent to participate
Exclusion Criteria:
* Volunteers with chronic diseases, including cardiovascular diseases, liver diseases, type 1 and type 2 diabetes autoimmune diseases and cancer
* Biological first-degree relatives (parents, brothers, sisters or children) who are or have suffered from one of the conditions described above
* Current smokers. Ex-smokers are suitable if they stopped smoking \>10 years ago
* Volunteers with a diagnosis of hypertension, or history of consistently high blood pressure readings, \>140/90 mmHg
* Volunteers with a diagnosis of hypercholesterolemia, or history of consistently high cholesterol levels, e.g. total cholesterol level \>6 mmol/l
* Volunteers have ≥3 alcoholic drinks per day
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03038750
Study Brief:
Protocol Section:
NCT03038750