Effects of Losartan on Insulin Resistance in Patients With Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
losartan
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Insulin Resistance, Losartan, ACE inhibitor, Inflammatory cytokine
Eligibility Criteria
Inclusion Criteria:
- chronic stable heart failure
Exclusion Criteria:
- renal dysfunction or under treatment with antidiabetic agents
Sites / Locations
Outcomes
Primary Outcome Measures
insulin resistance
Secondary Outcome Measures
inflammatory cytokines
Full Information
NCT ID
NCT00663377
First Posted
April 18, 2008
Last Updated
April 18, 2008
Sponsor
Tottori University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00663377
Brief Title
Effects of Losartan on Insulin Resistance in Patients With Heart Failure
Official Title
Losartan Improved Insulin Resistance and Decreased Inflammatory Cytokines in Patients With Chronic Heart Failure Treated With Angiotensin Converting Enzyme Inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tottori University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Insulin Resistance, Losartan, ACE inhibitor, Inflammatory cytokine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
losartan
Intervention Description
losartan 50-100mg for 16 weeks
Primary Outcome Measure Information:
Title
insulin resistance
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
inflammatory cytokines
Time Frame
16 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic stable heart failure
Exclusion Criteria:
renal dysfunction or under treatment with antidiabetic agents
12. IPD Sharing Statement
Citations:
PubMed Identifier
20827028
Citation
Ogino K, Kato M, Furuse Y, Kinugasa Y, Kaetsu Y, Mizuta E, Sugihara S, Ishida K, Yanagihara K, Hisatome I, Shigemasa C. Addition of losartan to angiotensin-converting enzyme inhibitors improves insulin resistance in patients with chronic heart failure treated without beta-blockers. Circ J. 2010 Nov;74(11):2346-52. doi: 10.1253/circj.cj-10-0395. Epub 2010 Sep 4.
Results Reference
derived
Learn more about this trial
Effects of Losartan on Insulin Resistance in Patients With Heart Failure
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