Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effects of intravenous 5-aminoimidazole-4-carboxamide ribonucleoside (AICAR) infusion on glucose and fat metabolism in type two diabetes
Acronym
Study hypothesis
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.
Ethics approval
Ethics approval received from the Medical Ethical Committee of the Radboud University Nijmegen Medical Centre (Nijmegen, The Netherlands) in May 2006 (ref: 2005/262).
Study design
Single-blinded randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Type two diabetes mellitus
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
5-aminoimidazole-4-carboxamide ribonucleoside (AICAR) infusion
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
01/06/2006
Overall trial end date
01/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Type two diabetes patients
2. Male
3. Aged 45 - 65 years
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
10
Participant exclusion criteria
1. Renal or liver dysfunction
2. Gout
3. Exogenous insulin therapy
Recruitment start date
01/06/2006
Recruitment end date
01/04/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Maastricht University
Maastricht
6229 ER
Netherlands
Sponsor information
Organisation
The Dutch Diabetes Research Foundation (The Netherlands)
Sponsor details
Division of Research
Stationsplein 139
Amersfoort
3818 LE
Netherlands
research@diabetesfonds.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Dutch Diabetes Research Foundation (The Netherlands) (ref: 2002.00.004)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary