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Acute Effects of Liothyronine in Single Administration

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ClinicalTrials.gov Identifier: NCT03098433
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : April 4, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 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

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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


Contacts
Contact: Francesco S Celi, MD, MHSc. 804-828-9696 francesco.celi@vcuhealth.org
Contact: Salvatore Carbone salvatore.carbone@vcuhealth.org

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Alanda Perry Jones, MA         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Francesco S Celi, MD, MHSc. Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03098433     History of Changes
Other Study ID Numbers: HM20005777
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No