- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00116207
An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
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Comparison of triple antioxidant combination therapy vs placebo.
Other Names:
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Placebo Comparator: Placebo
Placebo administered twice daily.
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Comparison of triple antioxidant combination therapy vs placebo.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline, 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, 24 months
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Systemic Oxidative Stress
Time Frame: 24 months
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ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection
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24 months
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Inflammation
Time Frame: 24 months
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High Sensitivity CRP (nmol/L)
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24 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eva L Feldman, MD, PhD, University of Michigan
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Diabetic Neuropathies
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites
- Protective Agents
- Micronutrients
- Vitamins
- Vitamin B Complex
- Free Radical Scavengers
- Gout Suppressants
- Antioxidants
- Allopurinol
- Niacinamide
Other Study ID Numbers
- IRB:2002-0460
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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