Dexamethasone Effect on miRNA Profile in Healthy Humans
Conditions
Brief summary
The proposed study will test dexamethasone effect on miRNA profile in healthy humans. As our data indicate that miRNA levels change over time, the investigators will study the time course of miRNA response to 1 mg IV dexamethasone within 60 minutes after injection. Dexamethasone is used routinely in human subjects for the treatment of inflammatory conditions and as a diagnostic tool in the evaluation of excess cortisol secretion (Cushing's syndrome). For the latter, 1 mg dexamethasone is given orally at midnight. Oral formula absorption in the gut can range from 20 to 60 minutes due to the presence of food and other factors. IV administration will bypass this variability and ensure an accurate and reproducible time-course study. The investigators will compare miRNA expression before and after dexamethasone treatment. The investigators will follow miRNA expression dynamics over a 1-hour time course to identify peak expression levels and to correlate miRNA expression with circulating dexamethasone levels. Dexamethasone and miRNA levels will be checked at baseline just before injection and then at 15, 30, 45, and 60 minutes after injection. Dexamethasone level is taken to verify treatment and to correlate it with miRNA expression.
Interventions
DRUGDexamethasone 4mg
1 mg IV dexamethasone will be pushed and miRNA levels will be checked at baseline just before injection and then at 15, 30, 45, and 60 minutes after injection.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults age ≥ 18
Exclusion criteria
* Pregnancy * Presence of a disease that affects HPA axis function * Current use of medications that affect cortisol secretion, such as opioid pain medication, anti-fungal agents, anti-epileptic agents, and glucocorticoids, including hydrocortisone, prednisone, dexamethasone, steroid-containing inhalers, and steroid injected into the joints * History of adverse event related to use of glucocorticoids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Time of Injection) miRNA Levels and 60 Minutes After Injection | Baseline and 60 minutes | The change of miRNA levels in blood between time of injection (baseline) and 60 minutes after injection. Expressed as miRx ratio: miR expression level normalized to miR7-2-1 expression level and divided by miRx expression at baseline (T0). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethesone Single arm study in which all healthy controls will receive 1 mg of dexamethasone intravenous (IV) injection.
Dexamethasone 4mg: 1 mg IV dexamethasone will be pushed and miRNA levels will be checked at baseline just before injection and then at 60 minutes after injection. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Dexamethesone | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 7 Participants | — |
| Age, Continuous | 31 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 7 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Change From Baseline (Time of Injection) miRNA Levels and 60 Minutes After Injection
The change of miRNA levels in blood between time of injection (baseline) and 60 minutes after injection. Expressed as miRx ratio: miR expression level normalized to miR7-2-1 expression level and divided by miRx expression at baseline (T0).
Time frame: Baseline and 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethesone | Change From Baseline (Time of Injection) miRNA Levels and 60 Minutes After Injection | 0.939288216 percentage of change | Standard Deviation 0.762951729 |
p-value: 0.9t-test, 2 sided