HealthyPhase 1/2NCT03098433
Effects of Liothyronine on Energy Expenditure and Cardiovascular Function
A Phase 1/2 study testing Liothyronine and Levothyroxine in people with Healthy, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study will assess the short term effects of a single dose of liothyronine on the cardiovascular system and energy expenditure Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Liothyronine and Levothyroxine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2017to 24 Jun 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI >20<30 kg/m2
- TSH >0.5<5.0 mcIU/mL
- Negative TPO antibodies
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
This study will assess the short term effects of a single dose of liothyronine on the cardiovascular system and energy expenditure
- Conditions
- Healthy
- Being tested
- Liothyronine, Levothyroxine, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiothyronineDrug
Single dose
LevothyroxineDrug
Active comparator
PlacebosDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Liothyronine | Experimental | Each participant will receive a single dose of lithyronine Receives: Drug: Liothyronine |
| Levothyroxine | Active comparator | Each participant will receive a single dose of levothyroxine Receives: Drug: Levothyroxine |
| Placebo | Placebo comparator | Each participant will receive a single dose of placebo Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
Cardiac output measured by Echocaridogram, Difference in Stroke Volume Pre- and Post- Drug Administration
Measured: five hours
Secondary outcomes (1)
Energy Expenditure
Energy expenditure measured by Whole-Room Indirect Calorimeter, Difference in energy Expenditure Pre- and Post- Drug Administration Kcal
Measured: five hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start20 Oct 2017
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double blind, crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco S Celi, MD, MHSc., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098433
- Sponsor's protocol ID
- HM20005777
- Status last verified
- Mar 2021
- First submitted
- 7 Mar 2017
- Last updated
- 26 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35295986
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Liothyronine on Energy Expenditure and Cardiovascular Function
- ClinicalTrials.gov ID
- NCT03098433
- Acronym / sponsor ID
- HM20005777
- Conditions
- Healthy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Posted 26 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the short term effects of a single dose of liothyronine on the cardiovascular system and energy expenditure
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- double blind, crossover
| Arm | Type | Receives |
|---|---|---|
| Liothyronine | Experimental | Drug: LiothyronineEach participant will receive a single dose of lithyronine |
| Levothyroxine | Active comparator | Drug: LevothyroxineEach participant will receive a single dose of levothyroxine |
| Placebo | Placebo comparator | Drug: PlacebosEach participant will receive a single dose of placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI >20<30 kg/m2
- TSH >0.5<5.0 mcIU/mL
- Negative TPO antibodies
Key exclusion criteria (8 listed)
- Pregnancy
- Use of prescription drugs
- Diabetes mellitus
- Coronary artery disease
- Hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiothyronineSingle dose | Drug | Liothyronine |
| LevothyroxineActive comparator | Drug | Levothyroxine |
| PlacebosPlacebo | Drug | Placebo |
Primary outcome
Cardiac Output
Time frame: five hours
Cardiac output measured by Echocaridogram, Difference in Stroke Volume Pre- and Post- Drug Administration
1 secondary outcome
Energy Expenditure
Time frame: five hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35295986Chen 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.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco S Celi, MD, MHSc. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Liothyronine and Levothyroxine in people with Healthy, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (time frame: five hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03098433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.