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Effects of Losartan on Insulin Resistance in Patients With Heart Failure

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ClinicalTrials.gov Identifier: NCT00663377
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : April 22, 2008
Sponsor:
Information provided by:
Tottori University Hospital

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 Type : Interventional  (Clinical Trial)
Estimated 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 : April 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources


Intervention Details:
    Drug: losartan
    losartan 50-100mg for 16 weeks


Primary Outcome Measures :
  1. insulin resistance [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. inflammatory cytokines [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic stable heart failure

Exclusion Criteria:

  • renal dysfunction or under treatment with antidiabetic agents

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kazuhide Ogino, Center for Clinical Residency Program, Tottori University Hospital
ClinicalTrials.gov Identifier: NCT00663377     History of Changes
Other Study ID Numbers: #656
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008

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

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