Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-01-09 @ 3:08 PM
Study NCT ID:
NCT00574834
Status:
TERMINATED
Last Update Posted:
2019-09-12
First Post:
2007-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes
Sponsor:
University of Maryland, Baltimore
Organization:
Study Overview
Official Title:
Mechanisms of Reduced Ramipril on the Onset of Type 2 Diabetes Mellitis
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will be focused on determining the integrated in-vivo mechanisms responsible for Ramipril's effects on delaying type 2 diabetes and restoring normal (blood sugar levels) glycemia in patients with impaired glucose tolerance.
Hypothesis - Ramipril effects will delay the onset of type 2 diabetes and restore normal glycemia in patients with impaired glucose tolerance.
Hypothesis - Ramipril effects will delay the onset of type 2 diabetes and restore normal glycemia in patients with impaired glucose tolerance.
Detailed Description:
Several studies have demonstrated that therapeutic agents used to reduce glucose levels and/or weight can delay the onset of type 2 diabetes. Intriguingly, angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) also result in reduction in the onset of type 2 DM. The most striking effect was found with Ramipril in the HOPE study. The onset of new type 2 DM was reduced by 34% (p\<0.001) as compared to placebo. Furthermore, the results of the DREAM trial demonstrate that Ramipril at a dose of 15 mg can significantly reverse impaired glucose tolerance. However, the mechanisms underlying Ramipril effects to delay type 2 diabetes are not known.
The proposal will be focused on determining the integrated in-vivo mechanisms responsible for Ramipril's effects on delaying type 2 DM and restoring normal glycemia in patients with impaired glucose tolerance.
The specific aims of the project are:
* to determine the effect of Ramipril on insulin resistance at the level of the liver and peripheral tissues,
* to determine the effect of Ramipril on endothelial function,
* to determine the effects of Ramipril on insulin secretion, and
* to determine the effects of Ramipril on substrate flux, lipolysis and inflammatory cytokines.
The proposal will be focused on determining the integrated in-vivo mechanisms responsible for Ramipril's effects on delaying type 2 DM and restoring normal glycemia in patients with impaired glucose tolerance.
The specific aims of the project are:
* to determine the effect of Ramipril on insulin resistance at the level of the liver and peripheral tissues,
* to determine the effect of Ramipril on endothelial function,
* to determine the effects of Ramipril on insulin secretion, and
* to determine the effects of Ramipril on substrate flux, lipolysis and inflammatory cytokines.
Study Oversight
Has Oversight DMC:
True
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?: