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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORAL ANTIOXIDANT | Experimental | 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. |
|
| Placebo | Placebo Comparator | Placebo administered twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORAL ANTIOXIDANT | Drug | Comparison of triple antioxidant combination therapy vs placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global [11C]HED Retention Index (RI) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Coronary Flow Reserve as a Measure of Endothelial Function | 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. | Baseline, 24 months |
| Systemic Oxidative Stress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva L Feldman, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23740194 | Derived | Pop-Busui R, Stevens MJ, Raffel DM, White EA, Mehta M, Plunkett CD, Brown MB, Feldman EL. Effects of triple antioxidant therapy on measures of cardiovascular autonomic neuropathy and on myocardial blood flow in type 1 diabetes: a randomised controlled trial. Diabetologia. 2013 Aug;56(8):1835-44. doi: 10.1007/s00125-013-2942-9. Epub 2013 Jun 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ORAL ANTIOXIDANT | Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo |
| FG001 | Placebo | Placebo administered twice daily. ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ORAL ANTIOXIDANT | Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Global [11C]HED Retention Index (RI) | 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. | Posted | Mean | Standard Deviation | Retention index | Baseline, 24 months |
|
At each subject visit adverse events were reviewed with the subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ORAL ANTIOXIDANT | Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Liver cancer resulting in death |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Serious Adverse Events | General disorders | Non-systematic Assessment | General complaints or concerns reported by participants that were non-serious, and mild to moderate in nature |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva L. Feldman, Professor of Internal Medicine | University of Michigan | 7347637274 | efeldman@med.umich.edu |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D003922 | Diabetes Mellitus, Type 1 |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D000975 | Antioxidants |
| D000493 | Allopurinol |
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D001685 | Biological Factors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection |
| 24 months |
| Inflammation | High Sensitivity CRP (nmol/L) | 24 months |
Placebo administered twice daily.
ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Placebo administered twice daily. ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo |
|
|
|
| Secondary | Global Coronary Flow Reserve as a Measure of Endothelial Function | 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. | Posted | Mean | Standard Deviation | ratio (rest:stress) | Baseline, 24 months |
|
|
|
|
| Secondary | Systemic Oxidative Stress | ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection | Posted | Mean | Standard Deviation | ng/G creatinine | 24 months |
|
|
|
|
| Secondary | Inflammation | High Sensitivity CRP (nmol/L) | Posted | Mean | Standard Deviation | nmol/L | 24 months |
|
|
|
|
| 1 |
| 22 |
| 18 |
| 22 |
| EG001 | Placebo | Placebo administered twice daily. ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo | 1 | 22 | 21 | 22 |
|
| Suicide Attempt | Psychiatric disorders | Systematic Assessment |
|
|
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| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020011 | Protective Agents |
| D045505 | Physiological Effects of Drugs |
| D020313 | Specialty Uses of Chemicals |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| ANOVA |
| 0.82 |
p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c. |
| 2-Sided |
| No |
| Superiority or Other |