Ignite Creation Date:
2024-05-06 @ 10:19 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03228732
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2017-07-20
Brief Title:
The Effects of Fluoxetine andor DHEA
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Effects of the Selective Serotonin Reuptake Inhibitor Fluoxetine andor DHEA on Neuroendocrine Autonomic Nervous System and Metabolic Counterregulatory Responses During Repeated Hypoglycemia in T1DM Individuals
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 To determine how the Selective Serotonin Reuptake Inhibitor SSRI fluoxetine Prozac an antidepressant often used to treat depression stimulates the participants bodys ability to defend against low blood sugar hypoglycemia 2 To learn how a hormone dehydroepiandrosterone DHEA stimulates the participants bodys ability to defend itself from low blood sugar hypoglycemia DHEA is a hormone produced naturally in the human body However it can be manufactured and is sold as an over-the-counter dietary supplement The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions 3 To study combined effects of fluoxetine and DHEA during low blood glucose In the present study the investigators will measure the participants bodys responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo a pill with no fluoxetine or DHEA Approximately 64 individuals with type 1 diabetes will take part in this study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None