The effects of 5-aminoimidazole-4-carboxamide ribonucleoside (AICAR) infusion in type two diabetes patients
| ISRCTN | ISRCTN31384581 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31384581 |
| Protocol serial number | N/A |
| Sponsor | The Dutch Diabetes Research Foundation (The Netherlands) |
| Funder | The Dutch Diabetes Research Foundation (The Netherlands) (ref: 2002.00.004) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Maastricht University
PO Box 616
Maastricht
6229 ER
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blinded randomised trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 5-aminoimidazole-4-carboxamide ribonucleoside (AICAR) infusion |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Plasma concentrations of: |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 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
6229 ER
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
