Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214825
Status:
COMPLETED
Last Update Posted:
2008-01-03
First Post:
2005-09-20
Brief Title:
Aldosterone and Vascular Disease in Diabetes Mellitus
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Aldosterone and Vascular Disease in Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2007-12
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:
Specific aims for this proposal are to determine in patients with diabetes mellitus the effects of an aldosterone receptor antagonist on
1 Coronary microvascular function assessed by MRI perfusion reserve
2 Endothelial dysfunction assessed by brachial artery reactivity studies and
3 Inflammation assessed by blood measurements of c-reactive protein CRP monocyte chemoattractant protein-1 MCP-1 and plasminogen activator inhibitor-1 PAI-1
1 Coronary microvascular function assessed by MRI perfusion reserve
2 Endothelial dysfunction assessed by brachial artery reactivity studies and
3 Inflammation assessed by blood measurements of c-reactive protein CRP monocyte chemoattractant protein-1 MCP-1 and plasminogen activator inhibitor-1 PAI-1
Detailed Description:
Recent human and animal studies suggest that activation of the mineralocorticoid receptor MR by aldosterone the final product of the renin-angiotensin-aldosterone system causes microvascular damage vascular inflammation and endothelial dysfunction Angiotensin converting enzyme ACE inhibitors and angiotensin receptor blockers ARBs are unable to provide long-term aldosterone suppression Therefore we hypothesize that activation of the MR contributes to progression of vascular disease in patients with diabetes already using ACE inhibitor therapy
Specific aims for this proposal are to determine in patients with type 1 or type 2 diabetes mellitus and proteinuria already receiving ACE inhibitor or ARB therapy the effects of an aldosterone receptor antagonist vs hydrochlorothiazide on
1 Coronary microvascular function assessed by MRI perfusion reserve
2 Endothelial dysfunction assessed by brachial artery reactivity studies
3 Inflammation and cellular oxidative stress and injury assessed by c-reactive protein CRP MCP-1 plasminogen activator inhibitor-1 PAI-1
4 Proteinuria and whether there is a differential effect when a MR antagonist or HCTZ is added to the ACE inhibitor therapy
This is a double-blind randomized cross-over study of men and women 21-64 years old with type 1 or type 2 diabetes mellitus and albuminuria ³30 mgg creatinine Participants will be randomized to a MR antagonist placebo or HCTZ potassium supplementation for 6 weeks The MR antagonist arm will receive eplerenone 50 mg daily The HCTZ arm will receive HCTZ 125 mg with potassium 10 Meq daily Amlodipine 5 to 10 mg daily will be added during run phase to control blood pressure Blood pressure goal is less than 13080 mm Hg There will be a 4-week washout period before the patients are crossed-over to the other study arm MRI perfusion reserve brachial artery reactivity and blood samples will be obtained at the beginning and end of each treatment arm
Specific aims for this proposal are to determine in patients with type 1 or type 2 diabetes mellitus and proteinuria already receiving ACE inhibitor or ARB therapy the effects of an aldosterone receptor antagonist vs hydrochlorothiazide on
1 Coronary microvascular function assessed by MRI perfusion reserve
2 Endothelial dysfunction assessed by brachial artery reactivity studies
3 Inflammation and cellular oxidative stress and injury assessed by c-reactive protein CRP MCP-1 plasminogen activator inhibitor-1 PAI-1
4 Proteinuria and whether there is a differential effect when a MR antagonist or HCTZ is added to the ACE inhibitor therapy
This is a double-blind randomized cross-over study of men and women 21-64 years old with type 1 or type 2 diabetes mellitus and albuminuria ³30 mgg creatinine Participants will be randomized to a MR antagonist placebo or HCTZ potassium supplementation for 6 weeks The MR antagonist arm will receive eplerenone 50 mg daily The HCTZ arm will receive HCTZ 125 mg with potassium 10 Meq daily Amlodipine 5 to 10 mg daily will be added during run phase to control blood pressure Blood pressure goal is less than 13080 mm Hg There will be a 4-week washout period before the patients are crossed-over to the other study arm MRI perfusion reserve brachial artery reactivity and blood samples will be obtained at the beginning and end of each treatment arm
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