Detection of miRNAs in HPA Axis Function in Healthy Subjects

Dexamethasone Effect on miRNA Profile in Healthy Humans Clinical Trial

Official title:

Detection of miRNAs in HPA Axis Function in Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04066647
• Other study ID #: Pro57715
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 9, 2019
• Est. completion date: July 24, 2019

Study information

• Verified date: July 2020
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 24, 2019
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dexamethasone Effect on miRNA Profile in Healthy Humans

Intervention

Drug:
• Dexamethasone 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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Altuvia Y, Landgraf P, Lithwick G, Elefant N, Pfeffer S, Aravin A, Brownstein MJ, Tuschl T, Margalit H. Clustering and conservation patterns of human microRNAs. Nucleic Acids Res. 2005 May 12;33(8):2697-706. Print 2005. — View Citation

Yamamoto M, Ben-Shlomo A, Kameda H, Fukuoka H, Deng N, Ding Y, Melmed S. Somatostatin receptor subtype 5 modifies hypothalamic-pituitary-adrenal axis stress function. JCI Insight. 2018 Oct 4;3(19). pii: 122932. doi: 10.1172/jci.insight.122932. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline and 60 minutes