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Effects of Losartan on Insulin Resistance in Patients With Heart Failure
This study has been completed.
Sponsor:
Tottori University Hospital
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
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | April 18, 2008 | ||
| Last Updated Date | April 18, 2008 | ||
| Start Date ICMJE | April 2006 | ||
| Primary Completion Date | Not Provided | ||
| Current Primary Outcome Measures ICMJE |
insulin resistance [ Time Frame: 16 weeks ] | ||
| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | No Changes Posted | ||
| Current Secondary Outcome Measures ICMJE |
inflammatory cytokines [ Time Frame: 16 weeks ] | ||
| Original Secondary Outcome Measures ICMJE | Same as current | ||
| Current Other Outcome Measures ICMJE | Not Provided | ||
| Original Other Outcome Measures ICMJE | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Effects of Losartan on Insulin Resistance in Patients With Heart Failure | ||
| Official Title ICMJE | Losartan Improved Insulin Resistance and Decreased Inflammatory Cytokines in Patients With Chronic Heart Failure Treated With Angiotensin Converting Enzyme Inhibitors | ||
| 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. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 4 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Heart Failure | ||
| Intervention ICMJE | Drug: losartan
losartan 50-100mg for 16 weeks |
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| Study Arms | Not Provided | ||
| Publications * | 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 β-blockers. Circ J. 2010 Nov;74(11):2346-52. Epub 2010 Sep 4. | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Estimated Enrollment ICMJE | 16 | ||
| Completion Date | March 2007 | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Senior | ||
| Accepts Healthy Volunteers | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Not Provided | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00663377 | ||
| Other Study ID Numbers ICMJE | #656 | ||
| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| Plan to Share Data | Not Provided | ||
| IPD Description | Not Provided | ||
| Responsible Party | Kazuhide Ogino, Center for Clinical Residency Program, Tottori University Hospital | ||
| Study Sponsor ICMJE | Tottori University Hospital | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Tottori University Hospital | ||
| Verification Date | April 2008 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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