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

This study has been completed.

Sponsor:

Collaborators:

National Health and Medical Research Council, Australia

Hoffmann-La Roche

Diabetes Australia

Information provided by:

Baker Heart Research Institute

ClinicalTrials.gov Identifier:

NCT00168519

First received: September 14, 2005

Last updated: December 14, 2009

Last verified: December 2009

History of Changes

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:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Contraction Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2 Exercise and Physical Fitness

Drug Information available for: Sodium nitroprusside Nitroprusside

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 ]


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

Arms	Assigned Interventions
Active Comparator: 1	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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


ClinicalTrials.gov Identifier:	NCT00168519 History of Changes
Other Study ID Numbers:	51/02
Study First Received:	September 14, 2005
Last Updated:	December 14, 2009
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:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases	Nitroprusside Antihypertensive Agents Vasodilator Agents Nitric Oxide Donors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016

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