Effects of Liothyronine on Energy Expenditure and Cardiov... | NCT03098433

NCT03098433

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liothyronine	Experimental	Each participant will receive a single dose of lithyronine	Drug: Liothyronine
Levothyroxine	Active Comparator	Each participant will receive a single dose of levothyroxine	Drug: Levothyroxine
Placebo	Placebo Comparator	Each participant will receive a single dose of placebo	Drug: Placebos

Name	Type	Description	Arm Group Labels	Other Names
Liothyronine	Drug	Single dose	Liothyronine
Levothyroxine

Outcomes Module

Measure	Description	Time Frame
Cardiac Output	Cardiac output measured by Echocaridogram, Difference in Stroke Volume Pre- and Post- Drug Administration	five hours

Secondary Outcomes

Measure	Description	Time Frame
Energy Expenditure	Energy expenditure measured by Whole-Room Indirect Calorimeter, Difference in energy Expenditure Pre- and Post- Drug Administration Kcal	five hours

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Francesco S Celi, MD, MHSc.	Virginia Commonwealth University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University		Richmond	Virginia	23298	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35295986	Derived	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.

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Three Treatments in Random Order	Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order. Information on the order of treatments was not collected. Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered. At the second study visit one of the remaining two treatments will be randomly selected and administered. At the third study visit the final treatment will be administered. The order of administration will not be analyzed therefore all participants are part of a single arm.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Three Treatments in Random Order	Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order. Information on the order of treatments was not collected. Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered. At the second study visit one of the remaining two treatments will be randomly selected and administered. At the third study visit the final treatment will be administered. The order of administration will not be tracked.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Cardiac Output

Cardiac output measured by Echocaridogram, Difference in Stroke Volume Pre- and Post- Drug Administration

I participant did not undergo echocardiogram

Posted

Mean

Standard Deviation

millilitres

five hours

ID	Title	Description
OG000	Three Treatments in Random Order	Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order Information on the order of treatments was not collected. Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered. At the second study visit one of the remaining two treatments will be randomly selected and administered. At the third study visit the final treatment will be administered. The order of administration will not be tracked.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Three Treatments in Random Order	Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order. Information on the order of treatments was not collected. Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered. At the second study visit one of the remaining two treatments will be randomly selected and administered. At the third study visit the final treatment will be administered. The order of administration will not be tracked.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Francesco S. Celi, MD, MHSc.	Virginia Commonwealth University	804-828-9696		francesco.celi@vcuhealth.org

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Sep 25, 2019	Apr 23, 2020	ICF_000.pdf
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 19, 2017	Mar 2, 2021	Prot_SAP_002.pdf

Intervention Browse Module

ID	Term
D014284	Triiodothyronine
D013974	Thyroxine

ID	Term
D013970	Thyronines
D013963	Thyroid Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists