Thyroid Cancer Clinical Trial
Official title:
Energy Metabolism in Thyroidectomized Patients
Verified date | May 2024 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | April 19, 2023 |
Est. primary completion date | April 19, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Quality of Life | ThyPRO-39, a thyroid specific quality of life instrument, was used to assess a participant's quality of life. ThyPRO-39 interrogates 12 individual domains and a composite on the 0 to 100 scale (0 best). A difference of 5 points corresponds to a small to moderate effect between two treatment arms. This outcome represents the change in score between when taken at baseline and then again at 6 months post surgery. The larger the increase in score, the better the improvement in the participant's quality of life. Each domain and the composite are being reported separately. | Baseline to 6 months post surgery | |
Primary | Short Term Change in Weight | Weight will be measured in kilograms using a stadiometer | Baseline to 6 months post surgery | |
Primary | Energy Expenditure (EE) | 24-hour EE will be measured using the whole room indirect calorimeter (WRIC) technique | Baseline to 6 months | |
Primary | Change in Cholesterol | Cholesterol will be measured using a standard lipid panel. | Baseline to 6 months post surgery |
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