NCT00168519

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

First QC Date

September 14, 2005

Last Update Submit

December 14, 2009

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2Blood GlucoseExerciseMuscle ContractionNitric OxideNitrates

Outcome Measures

Primary Outcomes (1)

  • glucose metabolism

    3 hours

Study Arms (1)

1

ACTIVE COMPARATOR
Drug: nitroprusside, pentalong, imdur, AICAR, isoptin

Interventions

nitroprusside, pentalong, imdur, AICAR, isoptinDRUG

Sodium Nitroprusside - one 30 minute intravenous infusion Pentalong - two tablets orally (total 160mg) Imdur - two tablets orally (total 120mg)

1

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baker Heart Research Institute

Melbourne, Victoria, 8008, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Interventions

Nitroprussideisosorbide-5-mononitrateAICA ribonucleotideVerapamil

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

FerricyanidesCyanidesAnionsIonsElectrolytesInorganic ChemicalsFerric CompoundsIron CompoundsHydrogen CyanideNitrogen CompoundsPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Bronwyn A Kingwell, PhD

    Baker Heart Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 15, 2005

Study Start

October 1, 2002

Study Completion

April 1, 2009

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations

AU(1)