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 @ 4:33 PM
Ignite Modification Date:
2025-12-24 @ 4:33 PM
NCT ID:
NCT00344266
Eligibility Criteria:
* INCLUSION CRITERIA:
* Age 25-45 years, male or female
* BMI 25.0-45.0 kg/m(2) for Overweight Subjects and 19.0-24.9 kg/m(2) for Non-Overweight Controls
* Healthy, as determined by medical history and laboratory tests
* Written informed consent
EXCLUSION CRITERIA:
* BMI less than 19.0 or greater than 45.0 kg/m(2)
* History or symptoms compatible with cardiovascular disease, including arrhythmias and syncopal episodes, or use of prescription medications for heart conditions, strokes, or peripheral vascular disease
* Allergy to lidocaine
* Pregnancy or breastfeeding
* Menopause or peri-menopausal period (FSH greater than 15 mIU/ml)
* Use of hormonal contraceptives or estrogen replacement therapy
* Alcohol (more than 2 drinks per day or CAGE greater than 2 questions and/or current/regular use of drugs such as amphetamines, cocaine, heroin, or marijuana
* Current use of tobacco products (smoking or chewing)
* History of Diabetes Mellitus, either type 1 or 2, or Fasting Glucose greater than 126 mg/dl
* Use of cholesterol- or lipid-lowering drugs, or fasting serum lipids in range requiring medication per Adult Treatment Panel III recommendations of the National Cholesterol Education Program
* Liver disease or ALT serum level greater than two-fold above the laboratory reference standard
* Renal insufficiency or estimated creatinine clearance less than or equal to 50 ml/min
* Current use of medications, dietary supplements (including fish oils), or alternative therapies known to alter thyroid function with the exception of occasional use of NSAIDs (3 tablets/week maximum) and Benzodiazepines; use of NSAIDs in the 10 days preceding the hospital admissions
* Current history, symptoms, or behavior compatible with psychiatric disorders or therapy with psychotropic medications that would be incompatible with safe and successful participation in this study
* History of drug or alcohol abuse within the last 5 years; current use of drugs or alcohol
* Keloid formation (relative to subcutaneous adipose tissue biopsies)
* Hypo- or hyperthyroidism (TSH greater than or equal to 10; less than or equal to 0.1 mIU/L)
* Blood pressure greater than 160/95 mm Hg or use of prescription medications for treatment of hypertension
* Cushing Syndrome
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
45 Years
Study:
NCT00344266
Study Brief:
Protocol Section:
NCT00344266