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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT04190069
Eligibility Criteria:
Inclusion Criteria:
1. Male or female aged 18 yrs or older
2. BMI \>40 kg/m2
3. BMI between 35-40 kg/m2 with obesity-related co-morbidities including type 2 diabetes mellitus, hypertension, dyslipidemia. Type 2 Diabetes Mellitus defined by A1c \>6.4% with or without oral hypoglycemic agents and with or without insulin therapy. Hypertension defined by blood pressure \>140/80 mm of hg with or without antihypertensive therapy. Dyslipidemia defined as fasting lipid profile with one or more of the following abnormalities: serum cholesterol levels \>200 mg/dl, serum triglyceride levels \>150 mg/dl, HDL levels \<50 mg/dl, LDL levels \>100 mg/dl with or without therapy.
Exclusion Criteria:
1. Binge eating disorder (Bulemia, Anorexia nervosa)
2. Congestive heart failure NYHA Class \>3
3. \>Stage 3 chronic kidney disease
4. Cardiovascular disease (non-fatal MI, non-fatal stroke, peripheral vascular disease) within the past 6 months of screening
5. Planned coronary artery, carotid artery or peripheral artery revascularization
6. Weight loss surgery (gastric bypass, sleeve gastrectomy, total/subtotal gastrectomy) within the past 2 yrs.
7. Pregnant and lactating females
8. Active malignancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04190069
Study Brief:
Protocol Section:
NCT04190069