An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Rodica Pop-Busui, University of Michigan
ClinicalTrials.gov Identifier:
NCT00116207
First received: June 27, 2005
Last updated: December 18, 2013
Last verified: December 2013
  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: ORAL ANTIOXIDANT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Retention Index (RI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial function [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 8-epi prostaglandin F2alpha [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • CRP [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: January 2000
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ORAL ANTIOXIDANT
Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally
Drug: ORAL ANTIOXIDANT
Comparison of triple antioxidant therapy to placebo
Other Names:
  • Allopurinol (300mg daily),
  • ALA (600mg twice daily)
  • nicotinamide (750 mg twice daily)
  • Placebo
Placebo Comparator: Placebo
Placebo administered twice daily.
Drug: ORAL ANTIOXIDANT
Comparison of triple antioxidant therapy to placebo
Other Names:
  • Allopurinol (300mg daily),
  • ALA (600mg twice daily)
  • nicotinamide (750 mg twice daily)
  • Placebo

  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
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: 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:
No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rodica Pop-Busui, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00116207     History of Changes
Other Study ID Numbers: IRB:2002-0460
Study First Received: June 27, 2005
Last Updated: December 18, 2013
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:
Nervous System Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014