Contraction (Exercise) Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes

This study has been completed.

First Received: September 14, 2005 Last Updated: December 14, 2009 History of Changes

Sponsor:	Baker Heart Research Institute
Collaborators:	National Health and Medical Research Council, Australia Hoffmann-La Roche Diabetes Australia
Information provided by:	Baker Heart Research Institute
ClinicalTrials.gov Identifier:	NCT00168519

Purpose

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.

Condition	Intervention
Diabetes Mellitus, Type 2	Drug: nitroprusside, pentalong, imdur, AICAR, isoptin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Contraction Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Exercise and Physical Fitness

Drug Information available for: Sodium nitroprusside Dextrose Nitroprusside Isosorbide-5-mononitrate Isosorbide dinitrate Isosorbide

U.S. FDA Resources

Further study details as provided by Baker Heart Research Institute:

Primary Outcome Measures:

glucose metabolism [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

NO [ Time Frame: 3 hours post ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2002
Study Completion Date:	April 2009

Arms	Assigned Interventions
1: Active Comparator	Drug: nitroprusside, pentalong, imdur, AICAR, isoptin Sodium Nitroprusside - one 30 minute intravenous infusion Pentalong - two tablets orally (total 160mg) Imdur - two tablets orally (total 120mg)

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Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168519

Locations

Australia, Victoria
Baker Heart Research Institute
Melbourne, Victoria, Australia, 8008

Sponsors and Collaborators

Baker Heart Research Institute

National Health and Medical Research Council, Australia

Hoffmann-La Roche

Diabetes Australia

Investigators

Principal Investigator:

Bronwyn A Kingwell, PhD

Baker Heart Research Institute

More Information

No publications provided

Study ID Numbers:	51/02
Study First Received:	September 14, 2005
Last Updated:	December 14, 2009
ClinicalTrials.gov Identifier:	NCT00168519 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Baker Heart Research Institute:

Diabetes Mellitus, Type 2
Blood Glucose
Exercise

Muscle Contraction
Nitric Oxide
Nitrates

Additional relevant MeSH terms:

Vasodilator Agents
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Nitric Oxide Donors
Therapeutic Uses
Diabetes Mellitus, Type 2
Nitroprusside
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010