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

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ClinicalTrials.gov Identifier: NCT00168519
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 15, 2009
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Hoffmann-La Roche
Diabetes Australia
Information provided by:
Baker Heart Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: nitroprusside, pentalong, imdur, AICAR, isoptin Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Contraction Mediated Glucose Uptake as a Therapeutic Target in Type 2 Diabetes
Study Start Date : October 2002
Actual Study Completion Date : April 2009

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Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. glucose metabolism [ Time Frame: 3 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168519


Locations
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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
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Principal Investigator: Bronwyn A Kingwell, PhD Baker Heart Research Institute
More Information
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ClinicalTrials.gov Identifier: NCT00168519     History of Changes
Other Study ID Numbers: 51/02
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009

Keywords provided by Baker Heart Research Institute:
Diabetes Mellitus, Type 2
Blood Glucose
Exercise
 Muscle Contraction
Nitric Oxide
Nitrates

Additional relevant MeSH terms:
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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