Thyroid and Glucose and Energy Metabolism

Completed · Phase 2

Conditions studied: Thyroid Diseases

In brief

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.

Key facts

Study ID

NCT00106119

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

18

Starts

2005-03-01

Expected to finish

2013-11-01

Last updated by the study team

2015-02-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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).

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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