Energy Metabolism in Thyroidectomized Patients
Thyroid Goiter, Hypothyroidism, Thyroid Cancer
About this trial
This is an interventional treatment trial for Thyroid Goiter
Eligibility Criteria
Inclusion Criteria:
- Clinical indication for total thyroidectomy
- TSH at screening >0.045<4.5mlU/m
- Adult men and women Age ≥18-89 years of age
- Euthyroid patients with clinical indication for total thyroidectomy
- Indication to total thyroidectomy for benign goiter or thyroid cancer not requiring suppressive thyroid hormone therapy
Exclusion Criteria:
- Weight <50 or >150 Kg
- Graves' disease
- Use of thyroid hormone therapy or thyroid supplements (at screening) except for multinodular goiter
- Indication for thyroid hormone suppressive therapy following surgery
- Uncontrolled arterial hypertension stage 2 or greater (>140/90 mm Hg at screening) while on medication (patients with hypertension controlled by therapy will be allowed to participate).
- Uncontrolled diabetes (HbA1c > 8.% at screening or Fructosamine > 325 mmol/L)
- History of cardiovascular disease, congestive heart failure or unstable coronary artery disease (angina, coronary event, or revascularization within 6 months); atrial fibrillation; or ventricular arrhythmia,
- History of major depression or psychosis
- Patients who are Pregnant, breastfeeding planned pregnancy within six months from the thyroidectomy
- Any conditions that in the opinion of the PI may impede the successful completion of the study
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Single therapy
Combination therapy
Levothyroxine (LT4) and placebo (a look-alike inactive substance, a "sugar pill") Patients in the LT4 group will be started at a dose of 1.6 mcg/Kg (52 The VCU Investigational Pharmacy will over-encapsulate LT4 plus placebo, in "AM" and "PM" color coded capsules. Patients will be instructed to take the AM drug first thing in the morning with water only, and to wait at least 30 minutes before taking other medications coffee or breakfast. The PM dose will be taken at least 30 minutes before dinner. Dose adjustments will be performed at the 6-week and 3-month follow up visits by an unblinded endocrinologist (Dr. Yavuz) aiming to achieve and maintain a target TSH within the normal range and within ± 0.5 mcIU/ml from the baseline (pre-surgery) TSH, Doses will be rounded to the nearest available formulation.
Liothyronine/levothyroxine (LT3/LT4) combination therapy. LT4/LT3 group will have 25 mcg of LT4 substituted with 5 mcg LT3 twice daily, to mimic the average daily T3 production form the thyroid The VCU Investigational Pharmacy will over-encapsulate LT4 plus 5 mcg LT3 in "AM" and "PM" color coded capsules. Patients will be instructed to take the AM drug first thing in the morning with water only, and to wait at least 30 minutes before taking other medications coffee or breakfast. The PM dose will be taken at least 30 minutes before dinner. Dose adjustments will be performed at the 6-week and 3-month follow up visits by an unblinded endocrinologist (Dr. Yavuz) aiming to achieve and maintain a target TSH within the normal range and within ± 0.5 mcIU/ml from the baseline (pre-surgery) TSH, Doses will be rounded to the nearest available formulation. No changes will be made in LT3.