Effects of Liothyronine on Energy Expenditure and Cardiovascular Function

March 2, 2021 updated by: Virginia Commonwealth University
This study will assess the short term effects of a single dose of liothyronine on the cardiovascular system and energy expenditure

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Francesco S Celi, MD, MHSc., Virginia Commonwealth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 20, 2017

Primary Completion (ACTUAL)

June 24, 2019

Study Completion (ACTUAL)

June 24, 2019

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

March 27, 2017

First Posted (ACTUAL)

March 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • HM20005777

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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