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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

Tracking Information
First Submitted Date  ICMJE March 7, 2017
First Posted Date  ICMJE March 31, 2017
Last Update Posted Date July 10, 2020
Actual Study Start Date  ICMJE October 20, 2017
Actual Primary Completion Date June 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
Cardiac output [ Time Frame: five hours ]
Stroke volume
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
Energy expenditure [ Time Frame: five hours ]
Kcal
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Liothyronine on Energy Expenditure and Cardiovascular Function
Official Title  ICMJE Effects of Liothyronine on Energy Expenditure and Cardiovascular Function
Brief Summary This study will assess the short term effects of a single dose of liothyronine on the cardiovascular system and energy expenditure
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
double blind, crossover
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Liothyronine
    Single dose
  • Drug: Levothyroxine
    Active comparator
  • Drug: Placebos
    Placebo
Study Arms  ICMJE
  • Experimental: Liothyronine
    Each participant will receive a single dose of lithyronine
    Intervention: Drug: Liothyronine
  • Active Comparator: Levothyroxine
    Each participant will receive a single dose of levothyroxine
    Intervention: Drug: Levothyroxine
  • Placebo Comparator: Placebo
    Each participant will receive a single dose of placebo
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2020)
26
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2017)
20
Actual Study Completion Date  ICMJE June 24, 2019
Actual Primary Completion Date June 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03098433
Other Study ID Numbers  ICMJE HM20005777
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francesco S Celi, MD, MHSc. Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP