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 @ 3:41 AM
Ignite Modification Date:
2025-12-25 @ 3:41 AM
NCT ID:
NCT07209202
Eligibility Criteria:
Inclusion Criteria:
* BMI 30 to 38 kg/m2 (obese group) or BMI 19 to 25 kg/m2 (lean group)
Exclusion Criteria:
* Pregnancy or lactation within the past six months;
* Type 1 or 2 diabetes mellitus (including fasting glucose ≥126 mg/dL, HgbA1c ≥6.5%);
* History of liver disease or AST and ALT 2x above the upper limit of normal;
* Fasting triglyceride \> 300 mg/dl; total cholesterol levels above the 95th percentile for age and sex;
* Hemoglobin (Hgb) \<12.5g/d or hematocrit\<3x Hgb value;
* Report of HIV or hepatitis B or C infection;
* History of cancer, other than basal cell or squamous cell carcinoma or kidney disease stage 3 or higher or patients currently on dialysis;
* Use of any anti-diabetic medications or hypolipidemic agents in the past six months;
* History of surgical procedure for obesity;
* Change in body weight \>5% in the past six months (by self-report);
* History of other conditions known to affect insulin sensitivity and lipid metabolism (e.g., polycystic ovary syndrome), history of galactosemia, hereditary fructose intolerance, or who test positive for fructose malabsorption at screening;
* Known intolerance to acetaminophen.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT07209202
Study Brief:
Protocol Section:
NCT07209202