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Energy Metabolism in Thyroidectomized Patients

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04782856
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
30.1
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Energy Metabolism in Thyroidectomized Patients
Actual Study Start Date :
Oct 28, 2020
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Drug: Levothyroxine
levothyroxine sodium tablet for oral use
Other Names:
  • L-Thryroxine

    • Drug: Placebo
    inert sugar tablets for oral use blinding for treatment of hypothyroidism
    Other Names:
  • Dextrose

    		•
    Experimental: 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.

    Drug: Levothyroxine
    levothyroxine sodium tablet for oral use
    Other Names:
  • L-Thryroxine

    • Drug: Liothyronine
    Liothyronine sodium tablets for oral use treatment of hypothyroidism
    Other Names:
  • Cytomel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Short term change in weight [Baseline to 6 months post surgery]

      Weight will be measured in kilograms using a stadiometer

    2. Energy expenditure (EE) [Baseline to 6 months]

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

    3. Change in cholesterol [Baseline to 6 months post surgery]

      Cholesterol will be measured using a standard lipid panel.

    Other Outcome Measures

    1. Change in Quality of Life [Baseline to 6 months post surgery]

      ThyPRO-39, a thyroid specific quality of life instrument

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Virginia Commonwealth University Richmond Virginia United States 23298

    Sponsors and Collaborators

    • Virginia Commonwealth University

    Investigators

    • Principal Investigator: Francesco S Celi, MD, MHSc, Virginia Commonwealth University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Virginia Commonwealth University
    ClinicalTrials.gov Identifier:
    NCT04782856
    Other Study ID Numbers:
    • HM20016169
    First Posted:
    Mar 4, 2021
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Thyroid Neoplasms
    Thyroid Diseases
    Hypothyroidism
    Goiter

    Study Results

    No Results Posted as of Apr 27, 2022