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An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00116207
First received: June 27, 2005
Last updated: July 27, 2010
Last verified: July 2010
History of Changes
  Purpose

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
Diabetic Autonomic Neuropathy
 Drug: allopurinal, alpha lipoic acid (ALA), nicotinamide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Retention Index (RI)

Secondary Outcome Measures:
  • Endothelial function
  • 8-epi prostaglandin F2alpha
  • CRP
  • Adverse events

Estimated Enrollment: 50
Study Start Date: January 2000
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes
  • A1C <9%
  • Mild neuropathy
  • Mild retinopathy
  • Mild nephropathy

Exclusion Criteria:

  • History of drug or alcohol dependence, heart disease, viral illness, liver disease, advanced kidney disease
  • Pregnant or nursing
  • Severely overweight
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116207

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Eva L Feldman, MD, PhD University of Michigan
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00116207     History of Changes
Other Study ID Numbers: IRB:2002-0460
Study First Received: June 27, 2005
Last Updated: July 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
Type 1 Diabetes
Oxidative Stress
Diabetic Complications
Neuropathy

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Diabetes Complications
Thioctic Acid
Niacinamide
Niacin
 Nicotinic Acids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Hypolipidemic Agents
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013