Thyroid Diseases Clinical Trial
Official title:
Peripheral Thyroid Hormone Conversion and Glucose and Energy Metabolism
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 have had their thyroid gland removed. Results of the study may
help in the development of better therapies to optimize blood sugar and cholesterol levels
in some patients.
Patients 18 years of age or older who have had most or all of their thyroid gland removed
and are taking long-term thyroid hormone medication may be eligible for this study after
screening.
Status | Completed |
Enrollment | 18 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
- 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). |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Arner P, Bolinder J, Wennlund A, Ostman J. Influence of thyroid hormone level on insulin action in human adipose tissue. Diabetes. 1984 Apr;33(4):369-75. — View Citation
Bakker SJ, ter Maaten JC, Popp-Snijders C, Slaets JP, Heine RJ, Gans RO. The relationship between thyrotropin and low density lipoprotein cholesterol is modified by insulin sensitivity in healthy euthyroid subjects. J Clin Endocrinol Metab. 2001 Mar;86(3):1206-11. — View Citation
Bartha T, Kim SW, Salvatore D, Gereben B, Tu HM, Harney JW, Rudas P, Larsen PR. Characterization of the 5'-flanking and 5'-untranslated regions of the cyclic adenosine 3',5'-monophosphate-responsive human type 2 iodothyronine deiodinase gene. Endocrinology. 2000 Jan;141(1):229-37. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Insulin-mediated Glucose Disposal Rate at Levothyroxine Treatment Phase | One month of therapy. | No | |
Primary | Insulin-mediated Glucose Disposal Rate at Liothyronine Treatment Phase | One month of therapy | No | |
Secondary | Total Cholesterol at Levothyroxine Treatment Phase | One month of therapy. | No | |
Secondary | Total Cholesterol at Liothyronine Treatment Phase | One month of therapy. | No | |
Secondary | Triglycerides at Levothyroxine Treatment Phase | One month of therapy. | No | |
Secondary | Triglycerides at Liothyronine Treatment Phase | One month of therapy. | No | |
Secondary | Resting Energy Expenditure at Levothyroxine Treatment Phase | One month of therapy. | No | |
Secondary | Resting Energy Expenditure at Liothyronine Treatment Phase | One month of therapy. | No | |
Secondary | Left Ventricle Mass Index at Levothyroxine Treatment Phase | One month of therapy. | No | |
Secondary | Left Ventricle Mass Index at Liothyronine Treatment Phase | One month of therapy. | No | |
Secondary | Apolipoprotein A-I at Levothyroxine Treatment Phase | One month of therapy. | No | |
Secondary | Apolipoprotein A-I at Liothyronine Treatment Phase | One month of therapy. | No | |
Secondary | Apolipoprotein B at Levothyroxine Treatment Phase | One month of therapy. | No | |
Secondary | Apolipoprotein B at Liothyronine Treatment Phase | One month of therapy. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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