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Effects of Losartan on Insulin Resistance in Patients With Heart Failure
This study has been completed.
First Received: April 18, 2008   No Changes Posted
Sponsored by: Tottori University Hospital
Information provided by: Tottori University Hospital
ClinicalTrials.gov Identifier: NCT00663377
  Purpose

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 Intervention Phase
Heart Failure
Drug: losartan
Phase IV

MedlinePlus related topics: Heart Failure
Drug Information available for: Insulin Losartan Losartan potassium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title: Losartan Improved Insulin Resistance and Decreased Inflammatory Cytokines in Patients With Chronic Heart Failure Treated With Angiotensin Converting Enzyme Inhibitors

Further study details as provided by Tottori University Hospital:

Primary Outcome Measures:
  • insulin resistance [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • inflammatory cytokines [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: April 2006
Study Completion Date: March 2007
Intervention Details:
    Drug: losartan
    losartan 50-100mg for 16 weeks
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic stable heart failure

Exclusion Criteria:

  • renal dysfunction or under treatment with antidiabetic agents
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Center for Clinical Residency Program, Tottori University Hospital ( Kazuhide Ogino )
Study ID Numbers: #656
Study First Received: April 18, 2008
Last Updated: April 18, 2008
ClinicalTrials.gov Identifier: NCT00663377     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Tottori University Hospital:
Heart Failure
Insulin Resistance
Losartan
ACE inhibitor
Inflammatory cytokine

Study placed in the following topic categories:
Heart Failure
Losartan
Heart Diseases
Metabolic Diseases
Cardiovascular Agents
Angiotensin II
Antihypertensive Agents
Insulin
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Hyperinsulinism
Angiotensin-Converting Enzyme Inhibitors
Insulin Resistance
Anti-Arrhythmia Agents
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Heart Failure
Losartan
Heart Diseases
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Hyperinsulinism
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Anti-Arrhythmia Agents
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009