Status:
COMPLETED
Thyroid and Glucose and Energy Metabolism
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Thyroid Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will examine how two thyroid preparations-levothyroxine (T4) and liothyronine (T3)-affect fat and cholesterol metabolism, blood sugar regulation, and thyrotropin secretion in patients who h...
Detailed Description
Thyroid hormone action plays an important role in the regulation of many physiologic processes, among them glucose and lipid metabolism. Interestingly, the clinical presentation of thyroid dysfunction...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age greater than or equal to 18 years, male or female.
- History of total or near total thyroidectomy or hypothyroidism on replacement therapy.
- For non-thyroidectomized patients, at least three-year history of replacement therapy (at least 1.2 mcg/Kg LT4/body weight), and less than 5% uptake at 24H on (123)I thyroid scan while on replacement therapy.
- Written informed consent.
- EXCLUSION CRITERIA:
- BMI less than or equal to 20 or greater than or equal to 30 kg/m(2).
- Metastatic thyroid cancer or history of thyroid cancer with high risk of recurrence requiring suppressive thyroid hormone therapy (Singer 1996).
- Significant thyroid residual greater than 1 mL as measured by ultrasound (limited to thyroidectomized patients) or greater than 5 percent uptake at 24H on (123)I thyroid scan while on replacement therapy (limited to hypothyroid patients not undergone total thyroidectomy).
- History or symptoms compatible with cardiovascular disease, including paroxysmal supraventricular tachycardia, atrial fibrillation, syncopal episodes or use of prescription medications for heart conditions, including antihypertensives.
- Allergy to lidocaine, isoproterenol, TRH, levothyroxine, liothyronine, Tylenol #3, oxycodone, nitroglycerin.
- Pregnancy or unwillingness to use non-hormonal contraception during the study.
- Breastfeeding
- Use of hormonal contraceptives or estrogen replacement therapy.
- Use of tobacco (smoking, chewing) for the two weeks preceding the hospital admissions (metabolic testing)
- Diabetes mellitus, either type I or II.
- 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.
- Use of medications/supplements/alternative therapies known to alter thyroid function.
- Current history or symptoms compatible with psychosis including major depression (including history of hospitalization for depression, history of attempted suicide, history of suicidal ideation).
- Use of antipsychotic medications
- History of drug or alcohol abuse within the last 5 years; current use of drugs or alcohol (CAGE greater than 3).
- Keloid formation (relative to skeletal muscle and subcutaneous adipose tissue biopsies).
- Current or previous clinically significant (requiring medical/surgical intervention) extrathyroidal manifestations of autoimmune thyroid disease (dermopathy, ophthalmopathy, arthropathy).
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00106119
Start Date
March 1 2005
End Date
November 1 2013
Last Update
February 23 2015
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892