Effects of Losartan on Insulin Resistance in Patients With Heart Failure

April 18, 2008 updated by: Tottori University Hospital

Losartan Improved Insulin Resistance and Decreased Inflammatory Cytokines in Patients With Chronic Heart Failure Treated With Angiotensin Converting Enzyme Inhibitors

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic stable heart failure

Exclusion Criteria:

  • renal dysfunction or under treatment with antidiabetic agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
insulin resistance
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
inflammatory cytokines
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tottori University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 18, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #656

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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