Energy Metabolism in Thyroidectomized Patients

Thyroid Cancer Clinical Trial

Official title:

Energy Metabolism in Thyroidectomized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782856
• Other study ID #: HM20016169
• Secondary ID: 1R21DK122310-01A
• Status: Completed
• Phase: Phase 2
• Start date: October 28, 2020
• Est. completion date: April 19, 2023

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Goiter
• Hypothyroidism
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Goiter

Intervention

Drug:
• Levothyroxine
levothyroxine sodium tablet for oral use
• Liothyronine
Liothyronine sodium tablets for oral use treatment of hypothyroidism
• Placebo
inert sugar tablets for oral use blinding for treatment of hypothyroidism

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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