Effects of Liothyronine on Energy Expenditure and Cardiovascular Function

NCT03098433 | Completed Phase 1 Results FDA Drug

• 1 other identifier: HM20005777
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Cardiac Output

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

  five hours

Secondary Outcomes (1)

• Energy Expenditure

  five hours

Study Arms (3)

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

Interventions

Liothyronine DRUG

Single dose

Liothyronine

Levothyroxine DRUG

Active comparator

Levothyroxine

Placebos DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 35295986 DERIVED

MeSH Terms

Interventions

Triiodothyronine; Thyroxine

Intervention Hierarchy (Ancestors)

Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Francesco S. Celi, MD, MHSc.
• Organization: Virginia Commonwealth University

francesco.celi@vcuhealth.org

804-828-9696

Study Officials

• Francesco S Celi, MD, MHSc.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double blind, crossover

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 31, 2017
• Study Start: October 20, 2017
• Primary Completion: June 24, 2019
• Study Completion: June 24, 2019
• Last Updated: March 26, 2021
• Results First Posted: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)