Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Liothyronine on Energy Expenditure and Cardiovascular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098433
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
This study will assess the short term effects of a single dose of liothyronine on the cardiovascular system and energy expenditure

Condition or disease Intervention/treatment Phase
Healthy Drug: Liothyronine Drug: Levothyroxine Drug: Placebos Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: double blind, crossover
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Effects of Liothyronine on Energy Expenditure and Cardiovascular Function
Actual Study Start Date : October 20, 2017
Actual Primary Completion Date : June 24, 2019
Actual Study Completion Date : June 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Liothyronine
Each participant will receive a single dose of lithyronine
Drug: Liothyronine
Single dose

Active Comparator: Levothyroxine
Each participant will receive a single dose of levothyroxine
Drug: Levothyroxine
Active comparator

Placebo Comparator: Placebo
Each participant will receive a single dose of placebo
Drug: Placebos
Placebo




Primary Outcome Measures :
  1. Cardiac output [ Time Frame: five hours ]
    Stroke volume


Secondary Outcome Measures :
  1. Energy expenditure [ Time Frame: five hours ]
    Kcal



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI >20<30 kg/m2
  • TSH >0.5<5.0 mcIU/mL
  • Negative TPO antibodies

Exclusion Criteria:

  • Pregnancy
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098433


Locations
Layout table for location information
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Layout table for investigator information
Principal Investigator: Francesco S Celi, MD, MHSc. Virginia Commonwealth University
  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:
Informed Consent Form  [PDF] September 25, 2019

Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03098433    
Other Study ID Numbers: HM20005777
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No