Effects of Losartan on Insulin Resistance in Patients With Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Tottori University Hospital
ClinicalTrials.gov Identifier:
NCT00663377
First received: April 18, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Tottori University Hospital

Additional 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
Study First Received: April 18, 2008
Last Updated: April 18, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Insulin
Losartan
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on September 14, 2014