Ignite Creation Date:
2024-05-06 @ 12:51 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01672255
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2012-08-17
Brief Title:
Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus DM
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Hypoglycemia Associated Autonomic Failure in Type 1 DM SSRI and Exercise
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:
Exercise is a cornerstone of diabetes management It helps reduce blood pressure promote weight loss lower insulin resistance and improve glucose and lipid triglyceride and HDL-cholesterol profiles Unfortunately the benefits of exercise are often not embraced by diabetic individuals because of the fear of low blood sugar hypoglycemia My laboratory has demonstrated that Autonomic nervous system ANS counterregulatory failure plays an important role in exercise associated hypoglycemia in Type 1 DM ANS responses are significantly reduced in Type 1 DM and are further blunted by antecedent episodes of hypoglycemia Furthermore there is a large sexual dimorphism of reduced ANS responses during submaximal exercise in both Type 1 DM and healthy individuals that is unexplained Accumulating data are demonstrating that serotonergic pathways can regulate ANS discharge Generally serotonergic pathways are inhibitory but both single and longer term administration of selective serotonin reuptake inhibitors SSRIs such as Prozac has been demonstrated to increase basal epinephrine levels and enhance baroreflex control of Sympathetic nervous system SNS activity What is unknown is whether fluoxetine can also enhance SNS responses and also override the large ANS sexual dimorphism present during sub maximal exercise Therefore the purpose of this study is to determine if the SSRI fluoxetine Prozac can improve SNS responses during exercise
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None