Energy Metabolism in Thyroidectomized Patients
Energy Metabolism in Thyroidectomized Patients
The purpose of this research study is to measure the changes in energy metabolism (how the
 body burns energy), cardiovascular function (heart function), and lipid metabolism
 (cholesterol break down and building) before and after thyroidectomy (surgical removal of
 thyroid gland) in response to two approved therapies for hypothyroidism: levothyroxine (LT4)
 or Liothyronine/levothyroxine (LT3/LT4) combination therapy.
In this study, Levothyroxine (LT4) and placebo (a look-alike inactive substance, a "sugar
 pill") will be compared to Liothyronine/ Levothyroxine (LT3/LT4) combination therapy.

 Levothyroxine LT4 and Liothyronine (LT3) are drugs approved by the U. S. Food and Drug
 Administration (FDA).

 All participants will be required follow VCU Health COVID-19 standard of Care screening
 procedures.

 This study requires approximately five study visits The five-study visits required will be a
 Screening Visit (outpatient), one Baseline Visit, (inpatient) one Six Week Visit,
 (outpatient), one Three Month Visit and one Six Month Visit (both inpatient). A COVID-19 test
 will be done 48 hours (2 days) before each of the three-inpatient visit, Baseline Visit,
 Three Month and Six Month Visit.

 Participants will be asked to:

 1. Give permission for the researchers to collect information about their medical history
 from participants and their medical records five times during the study visits and for 5
 years after the study visits.

 2. Have a Physical exam done 5 times

 3. 24-hour energy expenditure recording in the Whole room indirect calorimeter studies 3
 times (inpatient overnight stays: Baseline, Three months, and Six months visits)

 4. Study drug will be dispensed three times

 5. Have study drug dose adjustments two times

 6. Genomic blood draw for DNA one time

 7. Have blood drawn five times

 8. Have an DXA Scan two times

 9. Have an Echocardiogram three times

 10. Complete questionnaire three times

 11. Have Accelerometers sensors laced 3 times (inpatient overnight stays: Baseline, Three
 months, and Six months visits)

 12. ClearSight (blood pressure monitoring) procedure three times

 13. Be randomized to take either Levothyroxine LT4 + placebo group or
 LevothyroxineLT3/Liothyronine LT4 group from baseline through 6 months

 Participation in this study will last up to 6 months after surgery. Approximately 30 total
 individuals will participate in this study
Inclusion Criteria:

 1. Clinical indication for total thyroidectomy

 2. TSH at screening >0.045<4.5mlU/m

 3. Adult men and women Age ≥18-89 years of age

 4. Euthyroid patients with clinical indication for total thyroidectomy

 5. Indication to total thyroidectomy for benign goiter or thyroid cancer not requiring
 suppressive thyroid hormone therapy

 Exclusion Criteria:

 1. Weight <50 or >150 Kg

 2. Graves' disease

 3. Use of thyroid hormone therapy or thyroid supplements (at screening) except for
 multinodular goiter

 4. Indication for thyroid hormone suppressive therapy following surgery

 5. 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).

 6. Uncontrolled diabetes (HbA1c > 8.% at screening or Fructosamine > 325 mmol/L)

 7. 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,

 8. History of major depression or psychosis

 9. Patients who are Pregnant, breastfeeding planned pregnancy within six months from the
 thyroidectomy

 10. Any conditions that in the opinion of the PI may impede the successful completion of
 the study