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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01192373 |
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Date of registration:
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24/08/2010 |
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Primary sponsor: |
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Public title:
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Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function"
Metamod3 |
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Scientific title:
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Short Term Modulation of Circulating Free Fatty Acids in Heart Failure Patients With Type 2 Diabetes: "Effect on Myocardial Lipid Content, Left Ventricular Function and Exercise Capacity" |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01192373 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Roni R Nielsen, MD |
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Address:
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Telephone:
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0045 5121 9363 |
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Email:
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roni.r.nielse@hotmail.com |
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Affiliation:
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Name:
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Roni R Nielsen, MD |
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Address:
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Telephone:
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0045 5121 9363 |
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Email:
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roni.r.nielsen@gmail.com |
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Affiliation:
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Name:
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Roni R Nielsen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ejection fraction at or lower than 45%
- type 2 diabetes
Exclusion Criteria:
- known s-creatinine >220mM
- known S-alanine aminotransferase >3 times normal upper limit
- other disabilitating conditions
- pregnancy
- insulin treatment
Age minimum:
30 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes
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Heart Failure
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Intervention(s)
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Other: Metabolic substrate modulation
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Primary Outcome(s)
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Exercise capacity and oxygen consumption
[Time Frame: 1-6 weeks]
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intracellular lipid content
[Time Frame: 1-6 weeks]
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Left ventricular function
[Time Frame: 1-6 weeks]
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Secondary Outcome(s)
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6 minutes hall walk test
[Time Frame: 1-6 weeks]
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metabolic and hormonal profile
[Time Frame: 1-6 weeks]
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Regional left ventricular function
[Time Frame: 1-6 weeks]
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Secondary ID(s)
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M20090230
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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