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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT00402194
Eligibility Criteria:
Inclusion Criteria:
* Healthy
* Age 20-55
* Male and female
* Obese, defined as Males: BMI \>28 or \> 30% fat by DEXA scan or Bod Pod; Females: BMI \>30 or \> 33% fat by DEXA scan or Bod Pod
* Weight stable over at least 4 months
Exclusion Criteria:
* Diabetes mellitus (ADA criteria)
* Age \<20 or \> 55 yrs
* Blood pressure \>160/90 or \< 90/65 mmHg
* Total cholesterol \>240 or LDL cholesterol \>160 mg/dL
* Baseline elevations in AST or ALT \> 3X ULN
* Baseline elevation in creatinine \>1.6 ng/mL
* Unexplained baseline elevation in creatine kinase \> 3X ULN
* Concurrent significant chronic medical illness including, but not limited to, human immunodeficiency virus infection, Syphilis, hepatitis B infection, or hepatitis C infection
* Pregnancy
* Known hypersensitivity or intolerance to the study agents
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT00402194
Study Brief:
Protocol Section:
NCT00402194