An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
NCT ID: NCT00116207
Last Updated: 2016-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
44 participants
INTERVENTIONAL
2000-01-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ORAL ANTIOXIDANT
Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally These drugs were given together as a combination and not as individual treatment.
ORAL ANTIOXIDANT
Comparison of triple antioxidant combination therapy vs placebo.
Placebo
Placebo administered twice daily.
ORAL ANTIOXIDANT
Comparison of triple antioxidant combination therapy vs placebo.
Interventions
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ORAL ANTIOXIDANT
Comparison of triple antioxidant combination therapy vs placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A1C \<9%
* Mild neuropathy
* Mild retinopathy
* Mild nephropathy
Exclusion Criteria
* Pregnant or nursing
* Severely overweight
18 Years
65 Years
ALL
No
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
University of Michigan
OTHER
Responsible Party
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Rodica Pop-Busui
Associate Professor
Principal Investigators
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Eva L Feldman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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Pop-Busui R, Stevens MJ, Raffel DM, White EA, Mehta M, Plunkett CD, Brown MB, Feldman EL. Effects of triple antioxidant therapy on measures of cardiovascular autonomic neuropathy and on myocardial blood flow in type 1 diabetes: a randomised controlled trial. Diabetologia. 2013 Aug;56(8):1835-44. doi: 10.1007/s00125-013-2942-9. Epub 2013 Jun 6.
Other Identifiers
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IRB:2002-0460
Identifier Type: -
Identifier Source: org_study_id
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