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Sponsors and Collaborators: |
University of Michigan Juvenile Diabetes Research Foundation |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00116207 |
The focus of this project is cardiovascular diabetic autonomic neuropathy (DAN). DAN affects the nerves that control heart rate and blood flow to the heart in people with diabetes. DAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart. Three medications will be tested for their effectiveness in DAN.
Condition | Intervention | Phase |
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Diabetic Autonomic Neuropathy |
Drug: allopurinal, alpha lipoic acid (ALA), nicotinamide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cynthia Plunkett, RNC | 734 936 8065 | cplunket@umich.edu |
Contact: Martha M Funnell, MS, RN | 734 7635730 | mfunnell@umich.edu |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Cynthia Plunkett, RNC 734-936-8065 cplunket@umich.edu | |
Contact: Martha M Funnell, MS, RN 734 7635730 mfunnell@umich.edu | |
Principal Investigator: Eva L Feldman, MD, PhD |
Principal Investigator: | Eva L Feldman, MD, PhD | University of Michigan |
Study ID Numbers: | IRB:2002-0460 |
Study First Received: | June 27, 2005 |
Last Updated: | April 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00116207 |
Health Authority: | United States: Food and Drug Administration |
Type 1 Diabetes Oxidative Stress Diabetic Complications Neuropathy |
Niacinamide Diabetic Neuropathies Diabetes Mellitus Stress Endocrine System Diseases Nicotinic Acids Diabetes Mellitus, Type 1 |
Neuromuscular Diseases Peripheral Nervous System Diseases Endocrinopathy Niacin Diabetes Complications Thioctic Acid |
Antioxidants Vitamin B Complex Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins |
Physiological Effects of Drugs Nervous System Diseases Micronutrients Protective Agents Pharmacologic Actions |