search
Back to results

Energy Metabolism in Thyroidectomized Patients

Primary Purpose

Thyroid Goiter, Hypothyroidism, Thyroid Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Levothyroxine
Liothyronine
Placebo
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Goiter

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Single therapy

Combination therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Short term change in weight
Weight will be measured in kilograms using a stadiometer
Energy expenditure (EE)
24-hour EE will be measured using the whole room indirect calorimeter (WRIC) technique
Change in cholesterol
Cholesterol will be measured using a standard lipid panel.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2021
Last Updated
July 7, 2023
Sponsor
Virginia Commonwealth University
search

1. Study Identification

Unique Protocol Identification Number
NCT04782856
Brief Title
Energy Metabolism in Thyroidectomized Patients
Official Title
Energy Metabolism in Thyroidectomized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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: 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. Have a Physical exam done 5 times 24-hour energy expenditure recording in the Whole room indirect calorimeter studies 3 times (inpatient overnight stays: Baseline, Three months, and Six months visits) Study drug will be dispensed three times Have study drug dose adjustments two times Genomic blood draw for DNA one time Have blood drawn five times Have an DXA Scan two times Have an Echocardiogram three times Complete questionnaire three times Have Accelerometers sensors laced 3 times (inpatient overnight stays: Baseline, Three months, and Six months visits) ClearSight (blood pressure monitoring) procedure three times 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Goiter, Hypothyroidism, Thyroid Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Combination therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Other Intervention Name(s)
L-Thryroxine
Intervention Description
levothyroxine sodium tablet for oral use
Intervention Type
Drug
Intervention Name(s)
Liothyronine
Other Intervention Name(s)
Cytomel
Intervention Description
Liothyronine sodium tablets for oral use treatment of hypothyroidism
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Dextrose
Intervention Description
inert sugar tablets for oral use blinding for treatment of hypothyroidism
Primary Outcome Measure Information:
Title
Short term change in weight
Description
Weight will be measured in kilograms using a stadiometer
Time Frame
Baseline to 6 months post surgery
Title
Energy expenditure (EE)
Description
24-hour EE will be measured using the whole room indirect calorimeter (WRIC) technique
Time Frame
Baseline to 6 months
Title
Change in cholesterol
Description
Cholesterol will be measured using a standard lipid panel.
Time Frame
Baseline to 6 months post surgery
Other Pre-specified Outcome Measures:
Title
Change in Quality of Life
Description
ThyPRO-39, a thyroid specific quality of life instrument
Time Frame
Baseline to 6 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angeliki M Stamatouli, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Energy Metabolism in Thyroidectomized Patients

We'll reach out to this number within 24 hrs