Effects of Liothyronine on Energy Expenditure and Cardiovascular Function
NCT ID: NCT03098433
Last Updated: 2021-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2017-10-20
2019-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Liothyronine
Each participant will receive a single dose of lithyronine
Liothyronine
Single dose
Levothyroxine
Each participant will receive a single dose of levothyroxine
Levothyroxine
Active comparator
Placebo
Each participant will receive a single dose of placebo
Placebos
Placebo
Interventions
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Liothyronine
Single dose
Levothyroxine
Active comparator
Placebos
Placebo
Eligibility Criteria
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Inclusion Criteria
* TSH \>0.5\<5.0 mcIU/mL
* Negative TPO antibodies
Exclusion Criteria
* Use of prescription drugs
* Diabetes mellitus
* Coronary artery disease
* Hypertension
* Anemia
* Renal insufficiency
* Liver disease or ALT \>2.5 x the upper laboratory reference limit
18 Years
45 Years
ALL
Yes
Sponsors
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Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Francesco S Celi, MD, MHSc.
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Chen S, Wohlford GF, Vecchie' A, Carbone S, Yavuz S, Van Tassell B, Abbate A, Celi FS. Acute Effects of Liothyronine Administration on Cardiovascular System and Energy Metabolism in Healthy Volunteers. Front Endocrinol (Lausanne). 2022 Feb 28;13:843539. doi: 10.3389/fendo.2022.843539. eCollection 2022.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HM20005777
Identifier Type: -
Identifier Source: org_study_id
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