Energy Metabolism in Thyroidectomized Patients

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University

Criteria

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