Clinical trial NCT04782856: Energy Metabolism in Thyroidectomized Patients
Official title: Energy Metabolism in Thyroidectomized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Goiter
Hypothyroidism
Thyroid Cancer
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-03-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Eligibility 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

Primary outcomes:
measure: Short Term Change in Weight
timeFrame: Baseline to 6 months post surgery
measure: Energy Expenditure (EE)
timeFrame: Baseline to 6 months
measure: Change in Cholesterol
timeFrame: Baseline to 6 months post surgery
Secondary outcomes:
Other outcomes:
measure: Change in Quality of Life
timeFrame: Baseline to 6 months post surgery
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Angeliki M Stamatouli, MD
role: PRINCIPAL_INVESTIGATOR
References: