Energy Metabolism in Thyroidectomized Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hypothyroidism
- Thyroid Cancer
- Thyroid Goiter
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 89 years
- Gender
- Both males and females
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 participant...
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
Tracking Information
- NCT #
- NCT04782856
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Francesco S Celi, MD, MHSc Virginia Commonwealth University