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Completed

NCT Number: NCT04782856

Energy Metabolism in Thyroidectomized Patients

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levothyroxine

Drug

levothyroxine sodium tablet for oral use

Other names: L-Thryroxine

liothyronine

Drug

Liothyronine sodium tablets for oral use treatment of hypothyroidism

Other names: Cytomel

Placebo

Drug

inert sugar tablets for oral use blinding for treatment of hypothyroidism

Other names: Dextrose

Primary outcomes

  1. Short Term Change in Weight

    Time frame: Baseline to 6 months post surgery

    Weight will be measured in kilograms using a stadiometer

  2. Energy Expenditure (EE)

    Time frame: Baseline to 6 months

    24-hour EE will be measured using the whole room indirect calorimeter (WRIC) technique

  3. Change in Cholesterol

    Time frame: Baseline to 6 months post surgery

    Cholesterol will be measured using a standard lipid panel.

Other outcomes

  1. Change in Quality of Life

    Time frame: Baseline to 6 months post surgery

    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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

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

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2021
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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