Status:
COMPLETED
Regulation of FGF21 by Nutritional Challenges
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Fasting
Non-alcoholic Fatty Liver Disease (NAFLD)
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The purpose of this study is to examine how acute nutritional challenges affect levels of several proteins involved in metabolism. These proteins will be measured in blood and fat tissue. This study ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 72-hour fast in healthy volunteers (Study Arm A):
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00968747
Start Date
July 1 2009
End Date
July 31 2023
Last Update
August 14 2023
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215