Status:
COMPLETED
Thyroid and Fat Tissue Metabolism
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Brief Summary
This study will use a technique called microperfusion to examine how thyroid hormones are involved in fat metabolism. The thyroid gland produces two kinds of hormones: T3 and T4. Some of the T4 is cha...
Detailed Description
This study will examine how two thyroid preparations, levothyroxine (T4) and liothyronine (T3), affect subcutaneous adipose tissue in normal subjects. Thyroid hormone plays an important role in the ma...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age greater than or equal to 18 years, male or female.
- Written informed consent.
- EXCLUSION CRITERIA:
- Hypo- or hyper-thyroid (history or TSH greater than 5.0 and less than 0.4 miU/L)
- Blood pressure greater than 140/90 mmHg \[17\] or current antihypertensive therapy
- History of cardiovascular disease
- BMI less than or equal to 20 or greater than or equal to 30 Kg/m(2).
- Diabetes mellitus (serum glucose greater than or equal to 126 mg/dL).
- Hypercholesterolemia (serum levels greater than or equal to 240 mg/dL), hypertriglyceridemia (plasma levels greater than or equal to 220 mg/dL) and/or use of antilipemic therapy.
- Liver disease or ALT serum level greater than two fold the upper laboratory reference limit.
- Renal insufficiency or estimated creatinine clearance less than or equal to 50 mL/min (Cockcroft method).
- History of illicit drug or alcohol abuse within the last 5 years; current use of 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.
- Allergy to ethanol, levothyroxine, liothyronine, isoproterenol, lidocaine.
- Pregnancy/breastfeeding.
- Current smoker
- All subjects will be fully informed of the aim, nature, and risks of the study prior to giving written informed consent.
Exclusion
Key Trial Info
Start Date :
April 3 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 8 2014
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00312715
Start Date
April 3 2006
End Date
July 8 2014
Last Update
October 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892