Status:
COMPLETED
Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs)
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Postprandial thermogenesis, or thermic effect of food are terms that describe the increase in utilization of energy by the human body following a meal. The mechanisms involved in this process are beli...
Detailed Description
Postprandial thermogenesis, or thermic effect of food are terms that describe the increase in utilization of energy by the human body following a meal. The mechanisms involved in this process are beli...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age greater than or equal to18 years, male or female
- Written informed consent
- EXCLUSION CRITERIA:
- Hypo- or hyperthyroidism (history or serum thyroid-stimulating hormone (TSH) greater than 5.0 or less than 0.4 miU/L)
- Blood pressure greater than 140/90 mmHg (26) or receiving antihypertensive therapy
- History of cardiovascular disease
- BMI less than or equal to 20 or greater than or equal to 27 Kg/m(2)
- Diabetes mellitus (fasting serum glucose greater than or equal to 126 mg/dL)
- Hyperlipidemia (serum total cholesterol greater than or equal to 240 mg/dL, triglycerides greater than or equal to 220 mg/dL, and/or use of antilipemic therapy)
- Liver disease or ALT serum concentrations greater than 1.5 times the upper laboratory reference limit
- Hyperbilirubinemia (serum total bilirubin greater than 1.5 mg/dL)
- Renal insufficiency or estimated creatinine clearance less than or equal to 50 mL/min (MDRD equation)
- Anemia (Hemoglobin concentration less than or equal to 11.1 g/dL females, and 12.7 g/dL males)
- History of cholecystectomy or cholelithiasis (by ultrasound at screening).
- History of malabsorption, or food allergies/intolerances that would preclude participant from consuming foods required for study
- Claustrophobia
- History of illicit drug or alcohol abuse within the last 5 years; current use of illicit drugs (by history) or alcohol (CAGE greater than 3)
- Psychiatric conditions or behavior that would be incompatible with safe and successful participation in this study
- Current use of medications/dietary supplements/alternative therapies known to alter thyroid function, energy expenditure or bile acid secretion
- History of weight loss or weight gain of greater than 3 percent body weight over the past 2 months (self-reported)
- Pregnancy/breastfeeding/hormonal contraceptive use and childbirth within the last 6 months
- Perimenopausal (as self-described within two years from onset of amenorrhea or current complaints of hot flashes)
- Current smoker
Exclusion
Key Trial Info
Start Date :
June 23 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00706381
Start Date
June 23 2008
End Date
August 21 2012
Last Update
July 22 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892