Healthy
Conditions
Brief summary
This study will assess the short term effects of a single dose of liothyronine on the cardiovascular system and energy expenditure
Interventions
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
double blind, crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Output | five hours | Cardiac output measured by Echocaridogram, Difference in Stroke Volume Pre- and Post- Drug Administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Energy Expenditure | five hours | Energy expenditure measured by Whole-Room Indirect Calorimeter, Difference in energy Expenditure Pre- and Post- Drug Administration Kcal |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Three Treatments in Random Order Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order.
Information on the order of treatments was not collected.
Participants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered.
At the second study visit one of the remaining two treatments will be randomly selected and administered.
At the third study visit the final treatment will be administered.
The order of administration will not be tracked. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Three Treatments in Random Order |
|---|---|
| Age, Continuous | 27.7 years STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Cardiac Output
Cardiac output measured by Echocaridogram, Difference in Stroke Volume Pre- and Post- Drug Administration
Time frame: five hours
Population: I participant did not undergo echocardiogram
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Three Treatments in Random Order | Cardiac Output | Liothyronine | -3.7 millilitres | Standard Deviation 8.8 |
| Three Treatments in Random Order | Cardiac Output | Levothyroxine | -1.4 millilitres | Standard Deviation 6.5 |
| Three Treatments in Random Order | Cardiac Output | Placebo | 1 millilitres | Standard Deviation 6.2 |
Secondary
Energy Expenditure
Energy expenditure measured by Whole-Room Indirect Calorimeter, Difference in energy Expenditure Pre- and Post- Drug Administration Kcal
Time frame: five hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Three Treatments in Random Order | Energy Expenditure | Liothyronine | 0.006 kcal | Standard Deviation 0.067 |
| Three Treatments in Random Order | Energy Expenditure | Levothyroxine | -0.05 kcal | Standard Deviation 0.058 |
| Three Treatments in Random Order | Energy Expenditure | Placebo | -0.007 kcal | Standard Deviation 0.062 |