Status:
COMPLETED
Energy Metabolism in Thyroidectomized Patients
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Thyroid Goiter
Hypothyroidism
Eligibility:
All Genders
18-89 years
Phase:
PHASE2
Brief 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 an...
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 L...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04782856
Start Date
October 28 2020
End Date
April 19 2023
Last Update
June 14 2024
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298