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An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00116207
Recruitment Status : Completed
First Posted : June 28, 2005
Results First Posted : January 5, 2016
Last Update Posted : July 29, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Autonomic Neuropathy Drug: ORAL ANTIOXIDANT Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial
Study Start Date : January 2000
Primary Completion Date : September 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Drug: ORAL ANTIOXIDANT
Comparison of triple antioxidant combination therapy vs placebo.
Other Names:
  • Allopurinol (300mg daily),
  • ALA (600mg twice daily)
  • nicotinamide (750 mg twice daily)
Placebo Comparator: Placebo
Placebo administered twice daily.
Drug: ORAL ANTIOXIDANT
Comparison of triple antioxidant combination therapy vs placebo.
Other Names:
  • Allopurinol (300mg daily),
  • ALA (600mg twice daily)
  • nicotinamide (750 mg twice daily)


Outcome Measures

Primary Outcome Measures :
  1. Global [11C]HED Retention Index (RI) [ Time Frame: Baseline, 24 months ]

    Distal defects in [11C]meta-hydroxyephedrine ([11C]HED) retention involving at least 10 % of the left ventricle was used to define Cardiac Autonomic Neuropathy (CAN). The retention index (RI) is the unit of measure and is expressed as [11C]HEDblood min -1[ml tissue]-1

    PET Data of Randomized Subjects at Baseline and 24-Months

    The primary outcome was the change in the global [11C]HED RI = measure of cardiac innervation at 24 months in participants taking the active drug compared with those on placebo.



Secondary Outcome Measures :
  1. Global Coronary Flow Reserve as a Measure of Endothelial Function [ Time Frame: Baseline, 24 months ]
    global myocardial blood flow reserve as a measure of endothelial function. Measured by PET using [13N]ammonia at rest and during adenosine stimulated coronary vasodilation.

  2. Systemic Oxidative Stress [ Time Frame: 24 months ]
    ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection

  3. Inflammation [ Time Frame: 24 months ]
    High Sensitivity CRP (nmol/L)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): 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

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
First Posted: June 28, 2005    Key Record Dates
Results First Posted: January 5, 2016
Last Update Posted: July 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rodica Pop-Busui, University of Michigan:
Type 1 Diabetes
Oxidative Stress
Diabetic Complications
Neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Antioxidants
Allopurinol
Niacin
Niacinamide
Nicotinic Acids
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimetabolites
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Vasodilator Agents