Aldosterone and Vascular Disease in Diabetes Mellitus

NCT00214825 | Completed

• 1 other identifier: 2003-P-001273 BWH
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Specific aims for this proposal are to determine in patients with diabetes mellitus the effects of an aldosterone receptor antagonist on:

1. 1.Coronary microvascular function assessed by MRI perfusion reserve,
2. 2.Endothelial dysfunction assessed by brachial artery reactivity studies, and
3. 3.Inflammation assessed by blood measurements of c-reactive protein (CRP), monocyte chemoattractant protein-1 (MCP-1), and plasminogen activator inhibitor-1 (PAI-1).

Conditions

Diabetes Mellitus; Endothelial Dysfunction; Albuminuria

Outcome Measures

Primary Outcomes (1)

• Coronary microvascular function assessed by myocardial perfusion reserve measured by MRI

  20 weeks

Secondary Outcomes (3)

• Endothelial dysfunction assessed by brachial artery reactivity

  20 weeks

• Inflammation and cellular oxidative stress and injury, assessed by CRP, MCP-1, PAI-1, nephrin, cystanin C, F2 isoprostanes, and urinary 12-HETE

  20 weeks

• Proteinuria

  20 weeks

Study Arms (2)

1

EXPERIMENTAL

MR antagonist (Eplerenone) + placebo

Drug: eplerenone

2

PLACEBO COMPARATOR

Hydrochlorothiazide plus potassium

Drug: Hydrochlorothiazide

Interventions

eplerenone DRUG

50 mg daily for 6 weeks with placebo

1

Hydrochlorothiazide DRUG

HCTZ 12.5 mg with potassium (10 mEq) daily for 6 weeks

2

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women (21-64 years old) with type 1 or type 2 diabetes mellitus and albuminuria (over 30 mg/g creatinine).

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Joffe HV, Kwong RY, Gerhard-Herman MD, Rice C, Feldman K, Adler GK. Beneficial effects of eplerenone versus hydrochlorothiazide on coronary circulatory function in patients with diabetes mellitus. J Clin Endocrinol Metab. 2007 Jul;92(7):2552-8. doi: 10.1210/jc.2007-0393. Epub 2007 May 8.

  PMID: 17488800 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Albuminuria

Interventions

Eplerenone; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gail K Adler, MD, PhD

  Brigham and Women's Hospital Boston, MA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2003
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: January 3, 2008

Record last verified: 2007-12

Locations

US (1)