Phase 2
Completed N=13
Energy Metabolism in Thyroidectomized Patients
Thyroid Goiter · Hypothyroidism · Thyroid Cancer
Source: ClinicalTrials.gov NCT04782856 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Short Term Change in Weight — 1.7; -0.76 Kilogram
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short Term Change in Weight |
1.7; -0.76 | — |
| PRIMARY Energy Expenditure (EE) |
-39; 25 | — |
| PRIMARY Change in Cholesterol |
43; -35 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical indication for total thyroidectomy
- TSH at screening >0.045 150 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
Data sourced from ClinicalTrials.gov (NCT04782856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.