Regulation of FGF21 by Nutritional Challenges

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Aug 28, 2009

Keywords

ClinConnect Summary

Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to 5 different sweet beverages, separated by 2 weeks.

Gender

ALL

Eligibility criteria

• 72-hour fast in healthy volunteers (Study Arm A):
• Inclusion Criteria:
• • Age 18-50 years
• • Body Mass Index 21-26 kg/m\^2
• • Ability to give informed consent
• • Ability to follow verbal and written instructions in English
• 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):
• Inclusion Criteria:
• • Age 18-60
• • BMI 25-45 kg/m\^2
• • Known nonalcoholic fatty liver disease based on liver biopsy
• • Ability to give informed consent
• • Ability to follow verbal and written instructions in English
• Exclusion Criteria:
• • 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