Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/06/2008
Date assigned
13/06/2008
Last edited
13/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Hanneke Boon

ORCID ID

Contact details

Maastricht University
PO Box 616
Maastricht
6229 ER
Netherlands

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

http://www.diabetesfonds.nl/

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

Publication citations

Additional files

Editorial Notes