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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00168519




Registration number
NCT00168519
Ethics application status
Date submitted
14/09/2005
Date registered
15/09/2005
Date last updated
15/12/2009

Titles & IDs
Public title
Contraction (Exercise) Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes
Scientific title
Contraction Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes
Secondary ID [1] 0 0
51/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - nitroprusside, pentalong, imdur, AICAR, isoptin

Active comparator: 1 -


Treatment: Drugs: nitroprusside, pentalong, imdur, AICAR, isoptin
Sodium Nitroprusside - one 30 minute intravenous infusion

Pentalong - two tablets orally (total 160mg)

Imdur - two tablets orally (total 120mg)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
glucose metabolism
Timepoint [1] 0 0
3 hours

Eligibility
Key inclusion criteria
Patients with type 2 diabetes

* Non-smokers
* Free of overt coronary disease (stress ECG)
* Body mass index < 35 kg.m-2
* Fasting plasma glucose > 7 mmol.L-1 and / or post 75 gm oral glucose load plasma glucose levels of > 11.1 mmol.L-1
* Unmedicated (diet controlled)

Healthy controls

* Non-smokers
* Free of overt coronary disease (ECG)
* Body mass index < 30 kg.m-2
* Fasting plasma glucose < 6.1 mmol.L-1
* Unmedicated
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
8008 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Hoffmann-La Roche
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Diabetes Australia
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this project is to determine whether glucose metabolism can be improved by administering a substance (nitric oxide donor) normally released by muscles during exercise.
Trial website
https://clinicaltrials.gov/study/NCT00168519
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bronwyn A Kingwell, PhD
Address 0 0
Baker Heart Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00168519