Effects of Losartan on Insulin Resistance in Patients With Heart Failure

• Sponsor: Tottori University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00663377
• Collaborator: (none)
• Enrollment: 16
• Duration (Months): 11

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of losartan, an ARB, on glucose metabolism and inflammatory cytokines in CHF patients treated with ACE inhibitors.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: losartan	Phase 4

Detailed Description

Chronic heart failure (CHF) is associated with marked insulin resistance, characterized by both fasting and stimulated hyperinsulinemia. Furthermore, insulin resistance is a predictor of CHF and associated with more severe disease and a worse prognosis in patients with CHF. In CHF patients, therefore, insulin resistance is not merely a function of adiposity and may have implications in the pathophysiology of CHF disease progression. Angiotensin II negatively modulates insulin-mediated actions by regulating multiple levels of the insulin signaling cascade such as the insulin receptor, IRS, and PI3-kinase. Furthermore, both ACE inhibitors and angiotensin II receptor blockers (ARB) improve glycemic status not only in patients with type II diabetes but also in patients with hypertension and the metabolic syndrome. On the other hand, it is well known that some cytokines, such as TNF-α, are involved with pathophysiology of insulin resistance and CHF. However, it is still unclear whether the ARB improves insulin resistance in CHF patients already treated with ACE inhibitors and whether there is the relationship between insulin resistance and inflammatory cytokines in CHF patients already treated with ACE inhibitors. Therefore, the purpose of this study is to evaluate the effects of losartan, an ARB, on glucose metabolism and inflammatory cytokines in CHF patients treated with ACE inhibitors.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Losartan Improved Insulin Resistance and Decreased Inflammatory Cytokines in Patients With Chronic Heart Failure Treated With Angiotensin Converting Enzyme Inhibitors
• Study Start Date: Apr 1, 2006
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

Primary Outcome Measures

1. insulin resistance [16 weeks]

Secondary Outcome Measures

1. inflammatory cytokines [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• chronic stable heart failure

Exclusion Criteria:

• renal dysfunction or under treatment with antidiabetic agents

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tottori University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00663377
• Other Study ID Numbers: #656
• First Posted: Apr 22, 2008
• Last Update Posted: Apr 22, 2008
• Last Verified: Apr 1, 2008

• Keywords provided by , ,: Heart Failure; Insulin Resistance; Losartan; ACE inhibitor; Inflammatory cytokine
• Additional relevant MeSH terms: Heart Failure; Insulin Resistance; Losartan

Study Results

No Results Posted as of Apr 22, 2008