Regulation of FGF21 by Nutritional Challenges

Exclusion Criteria

• •Type 1 or Type 2 diabetes mellitus diagnosed according to the American Diabetes Association criteria
• •Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
• •Tobacco, marijuana, or intravenous drug use within 1 year of screening visit
• •Recent weight change (\>3 kg within 6 months of screening visit)
• •Malignancy treated with chemotherapy within past 3 years
• •History of depression, psychosis, or other psychiatric illness requiring hospitalization
• •History of hyperthyroidism
• •Renal insufficiency (creatinine clearance \< 50 ml/min)
• •Transaminases \> 2X above the normal range
• •Known liver disease
• •Pregnancy within 12 months of screening visit
• •Lactation within 12 months of screening visit
• •Failure to use medically approved contraceptive methods (oral contraceptive, 2 barrier methods, surgical sterilization)
• •History of an eating disorder (anorexia, bulimia, or laxative abuse)
• •History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
• •New diagnosis of hypothyroidism within 1 year of screening visit or change in dose of thyroid hormone within 3 months of screening visit
• •History of alcohol abuse within the past 3 years
• •History of keloid formation
• •History of allergy to lidocaine or marcaine
• •Use of plavix, coumadin, or heparin
• •72-hour fast or hypocaloric diet in subjects with non-alcoholic fatty liver disease (NAFLD) (Study Arms B \& C):
• •Type I diabetes mellitus diagnosed according to the American Diabetes Association criteria or Type II diabetes mellitus with A1c \> 7.5% or taking metformin or thiazolidinediones
• •Coronary Heart Disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
• •Uncontrolled hypertension (BP \> 150/90 mmHg on or off antihypertensive medication)
• •Tobacco, marijuana, or intravenous drug use within 1 year of screening visit
• •Recent weight change (\> 3 kg within 6 months of screening visit)
• •Malignancy treated with chemotherapy within the past 3 years
• •History of depression, psychosis, or other psychiatric illness requiring hospitalization
• •History of hypo or hyperthyroidism
• •Renal insufficiency (creatinine clearance \< 50 ml/min)
• •Pregnancy within 12 months of screening visit
• •Lactation within 12 months of screening visit
• •Failure to use medically approved contraceptive methods (oral contraceptive, 2 barrier methods, surgical sterilization)
• •History of an eating disorder (anorexia, bulimia, or laxative abuse)
• •History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
• •New diagnosis of hypo or hyperthyroidism within 1 year of screening visit or change in dose of thyroid hormone within 3 months of screening visit
• •History of alcohol abuse within the past 3 years
• •Cardiac pacemaker or aneurysm clips
• •Metal implants in the body (pins, plates, shrapnel, intact bullets, IUD)
• •Claustrophobia