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 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT02948569
Eligibility Criteria:
Inclusion Criteria:
1. Men with characteristics of metabolic syndrome
1. Waist circumference greater than 40 in (102 cm)
2. Plasma TG greater than 150 mg/dL
3. HDL cholesterol less than 40 mg/dL
4. Blood pressure greater than or equal to 130/85 mmHg
5. Fasting plasma glucose greater than 100 mg/dL but less than 126 mg/dL
6. Fasting insulin great than 10 microunits/mL
2. 35-60 years of age
3. Overweight/obese subjects with BMI 27.1 - 35.0 kg/m2
4. Family history of cardiovascular disease or diabetes
5. Habitual diets containing ≥ 5.0% of energy from added sugars
6. Creatinine clearance of ≥80 mL/min
Exclusion Criteria:
1. Diagnosed cardiovascular disease (unstable angina, New York Heart Association angina \> Grade 2), abnormal thyroid function or liver/kidney disease, renal dysfunction (defined by a glomerular filtration rate \<80 mL/min)
2. Chronic skin disorder or treatment for acne
3. History of clinically significant dry eye or eye diseases such as glaucoma
4. Diabetes defined as fasting glucose ≥ 125 mg/dL or HbA1c ≥ 6.5%
5. Habitual diets with low content of added sugars (\<5% of total energy)
6. Any tobacco use
7. Elevated liver enzymes ≥ 3x normal (regional norms Alanine transaminase \<42 U/L, aspartate aminotransferase \<40 U/L, and gamma-glutamyl transferase 8-61 U/L)
8. Contraindications of MRI
9. Alcohol intake weekly greater than 56 g/week (4 standard drinks/wk).
10. Major surgery or donation of blood of \>500 mL within the past 8 wks.
11. Patients with uncontrolled hypertension, i.e. ≥160/95 mmHg.
12. Patients with known cardiac abnormalities.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
35 Years
Maximum Age:
60 Years
Study:
NCT02948569
Study Brief:
Protocol Section:
NCT02948569