The effects of 5-aminoimidazole-4-carboxamide ribonucleoside (AICAR) infusion in type two diabetes patients
| ISRCTN | ISRCTN31384581 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31384581 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/06/2008
- Registration date
- 13/06/2008
- Last edited
- 30/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Hanneke Boon
Scientific
Scientific
Maastricht University
PO Box 616
Maastricht
6229 ER
Netherlands
Study information
| Study design | Single-blinded randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The effects of intravenous 5-aminoimidazole-4-carboxamide ribonucleoside (AICAR) infusion on glucose and fat metabolism in type two diabetes |
| Study objectives | 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(s) | Ethics approval received from the Medical Ethical Committee of the Radboud University Nijmegen Medical Centre (Nijmegen, The Netherlands) in May 2006 (ref: 2005/262). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 5-aminoimidazole-4-carboxamide ribonucleoside (AICAR) infusion |
| Primary outcome measure | 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 study start date | 01/06/2006 |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Type two diabetes patients 2. Male 3. Aged 45 - 65 years |
| Key exclusion criteria | 1. Renal or liver dysfunction 2. Gout 3. Exogenous insulin therapy |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Maastricht University
Maastricht
6229 ER
Netherlands
6229 ER
Netherlands
Sponsor information
The Dutch Diabetes Research Foundation (The Netherlands)
Research organisation
Research organisation
Division of Research
Stationsplein 139
Amersfoort
3818 LE
Netherlands
| research@diabetesfonds.nl | |
| Website | http://www.diabetesfonds.nl/ |
"ROR" |
https://ror.org/04ch2g225 |
Funders
Funder type
Research organisation
The Dutch Diabetes Research Foundation (The Netherlands) (ref: 2002.00.004)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2008 | 30/12/2020 | Yes | No |
Editorial Notes
30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
