Virginia Commonwealth University
Richmond, Virginia, 23298, United States
NCT Number: NCT04782856
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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Notify Me18 year–89 year
All sexes
Interventional
Phase 2
Richmond, Virginia, 23298, United States
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:
Participation in this study will last up to 6 months after surgery. Approximately 30 total individuals will participate in this study
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
levothyroxine sodium tablet for oral use
Other names: L-Thryroxine
Liothyronine sodium tablets for oral use treatment of hypothyroidism
Other names: Cytomel
inert sugar tablets for oral use blinding for treatment of hypothyroidism
Other names: Dextrose
Time frame: Baseline to 6 months post surgery
Weight will be measured in kilograms using a stadiometer
Time frame: Baseline to 6 months
24-hour EE will be measured using the whole room indirect calorimeter (WRIC) technique
Time frame: Baseline to 6 months post surgery
Cholesterol will be measured using a standard lipid panel.
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.
Virginia Commonwealth University
Other
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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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