Energy Metabolism in Thyroidectomized Patients

NCT ID: NCT04782856

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2023-04-19

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

Conditions

Thyroid Goiter; Hypothyroidism; Thyroid Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Single therapy

Levothyroxine (LT4) and placebo (a look-alike inactive substance, a "sugar pill") Patients in the LT4 group will be started at a dose of 1.6 mcg/Kg (52 The VCU Investigational Pharmacy will over-encapsulate LT4 plus placebo, in "AM" and "PM" color coded capsules. Patients will be instructed to take the AM drug first thing in the morning with water only, and to wait at least 30 minutes before taking other medications coffee or breakfast. The PM dose will be taken at least 30 minutes before dinner. Dose adjustments will be performed at the 6-week and 3-month follow up visits by an unblinded endocrinologist (Dr. Yavuz) aiming to achieve and maintain a target TSH within the normal range and within ± 0.5 mcIU/ml from the baseline (pre-surgery) TSH, Doses will be rounded to the nearest available formulation.

Group Type: ACTIVE_COMPARATOR

Levothyroxine

Intervention Type: DRUG

levothyroxine sodium tablet for oral use

Placebo

Intervention Type: DRUG

inert sugar tablets for oral use blinding for treatment of hypothyroidism

Combination therapy

Liothyronine/levothyroxine (LT3/LT4) combination therapy. LT4/LT3 group will have 25 mcg of LT4 substituted with 5 mcg LT3 twice daily, to mimic the average daily T3 production form the thyroid The VCU Investigational Pharmacy will over-encapsulate LT4 plus 5 mcg LT3 in "AM" and "PM" color coded capsules. Patients will be instructed to take the AM drug first thing in the morning with water only, and to wait at least 30 minutes before taking other medications coffee or breakfast. The PM dose will be taken at least 30 minutes before dinner. Dose adjustments will be performed at the 6-week and 3-month follow up visits by an unblinded endocrinologist (Dr. Yavuz) aiming to achieve and maintain a target TSH within the normal range and within ± 0.5 mcIU/ml from the baseline (pre-surgery) TSH, Doses will be rounded to the nearest available formulation. No changes will be made in LT3.

Group Type: EXPERIMENTAL

Levothyroxine

Intervention Type: DRUG

levothyroxine sodium tablet for oral use

Liothyronine

Intervention Type: DRUG

Liothyronine sodium tablets for oral use treatment of hypothyroidism

Interventions

Levothyroxine

levothyroxine sodium tablet for oral use

Intervention Type: DRUG

Liothyronine

Liothyronine sodium tablets for oral use treatment of hypothyroidism

Intervention Type: DRUG

Placebo

inert sugar tablets for oral use blinding for treatment of hypothyroidism

Intervention Type: DRUG

Other Intervention Names

L-Thryroxine; Cytomel; Dextrose

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angeliki M Stamatouli, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21DK122310-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20016169

Identifier Type: -

Identifier Source: org_study_id