Energy Metabolism in Thyroidectomized Patients
Condition: Thyroid Goiter; Hypothyroidism; Thyroid Cancer
MeSH terms: Thyroid Diseases; Hypothyroidism; Goiter
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Levothyroxine; Liothyronine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): levothyroxine sodium tablet for oral use; Liothyronine sodium tablets for oral use treatment of hypothyroidism; inert sugar tablets for oral use blinding for treatment of hypothyroidism
Other intervention name(s): L-Thryroxine; Cytomel; Dextrose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment