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ISRCTN
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ISRCTN31384581
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ClinicalTrials.gov identifier
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Public title
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The effects of 5-aminoimidazole-4-carboxamide ribonucleoside (AICAR) infusion in type two diabetes patients
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Scientific title
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The effects of intravenous 5-aminoimidazole-4-carboxamide ribonucleoside (AICAR) infusion on glucose and fat metabolism in type two diabetes
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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To determine the impact of intravenous 5-aminoimidazole-4-carboxamide ribonucleoside (AICAR) administration on plasma glucose and fatty acid kinetics and skeletal muscle adenosine monophosphate (AMP)-activated protein kinase (AMPK) activation in vivo in type two diabetes patients.
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Ethics approval
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Ethics approval received from the Medical Ethical Committee of the Radboud University Nijmegen Medical Centre (Nijmegen, The Netherlands) in May 2006 (ref: 2005/262).
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Study design
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Single-blinded randomised trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Type two diabetes mellitus
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Participants - inclusion criteria
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1. Type two diabetes patients
2. Male
3. Aged 45 - 65 years
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Participants - exclusion criteria
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1. Renal or liver dysfunction
2. Gout
3. Exogenous insulin therapy
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Anticipated start date
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01/06/2006
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Anticipated end date
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01/04/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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10
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Interventions
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Each subject participates in two experimental tests; one test in which AICAR (0.75 mg/kg/min) is infused and one test in which only saline (0.9% NaCl) is infused to ensure equal volume administration. The trial consists of two test days separated by at least two weeks to allow wash-out. After 90 minutes of saline infusion, AICAR infusion was started for 120 minutes (so total duration of the infusion/day = 210 minutes). In the other test, no AICAR was infused, only saline. The order of the tests is randomised.
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Primary outcome measure(s)
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Tracer kinetics (rate of appearance and rate of disappearance) of glucose and free fatty acids. During both test days, outcomes were measured at the following timepoints: t = 0, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195 and 210 minutes.
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Secondary outcome measure(s)
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Plasma concentrations of:
1. Glucose
2. Free fatty acids (FFA)
3. Insulin
4. Lactate
5. Triglycerides
6. Free glycerol
During both test days, outcomes were measured at the following timepoints: t = 0, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195 and 210 minutes.
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Sources of funding
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The Dutch Diabetes Research Foundation (The Netherlands) (ref: 2002.00.004)
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Trial website
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Publications
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Contact name
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Miss
Hanneke
Boon
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Address
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Maastricht University
PO Box 616
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City/town
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Maastricht
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Zip/Postcode
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6229 ER
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Country
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Netherlands
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Sponsor
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The Dutch Diabetes Research Foundation (The Netherlands)
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Address
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Division of Research
Stationsplein 139
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City/town
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Amersfoort
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Zip/Postcode
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3818 LE
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Country
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Netherlands
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Email
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research@diabetesfonds.nl
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Sponsor website:
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http://www.diabetesfonds.nl/
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Date applied
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09/06/2008
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Last edited
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13/06/2008
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Date ISRCTN assigned
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13/06/2008
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