A Phase 3 interventional study of ORAL ANTIOXIDANT in Diabetic Autonomic Neuropathy, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-29.
Sponsored by University of Michigan · Phase 3, Interventional, and Treatment
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.
617 studies on the registry are indexed under Diabetic Neuropathies; 91 are open to participants now.
This study's enrollment of 44 is below the median of 73 across 510 interventional studies indexed under Diabetic Neuropathies.
Browse Diabetic Neuropathies studies →University of Michigan is the lead sponsor of 1,476 studies on the registry; 197 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Placebo administered twice daily.
Drug: ORAL ANTIOXIDANT
Comparison of triple antioxidant combination therapy vs placebo.
Also known as: Allopurinol (300mg daily),, ALA (600mg twice daily), nicotinamide (750 mg twice daily)
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.
Time frame: Baseline, 24 months
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.
Time frame: Baseline, 24 months
Systemic Oxidative Stress
ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection
Time frame: 24 months
Inflammation
High Sensitivity CRP (nmol/L)
Time frame: 24 months
| Milestone | ORAL ANTIOXIDANT | Placebo |
|---|---|---|
| Started | 22 | 22 |
| Completed | 13 | 18 |
| Not completed | 9 | 4 |
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.
| Retention index | ORAL ANTIOXIDANT | Placebo |
|---|---|---|
| BASELINE | 0.081 ± 0.017 | 0.073 ± 0.016 |
| 24 MONTHS | 0.070 ± 0.018 | 0.074 ± 0.016 |
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.
| ratio (rest:stress) | ORAL ANTIOXIDANT | Placebo |
|---|---|---|
| BASELINE | 2.95 ± 1.32 | 2.94 ± 1.70 |
| 24 MONTH | 3.02 ± 1.82 | 3.22 ± 0.85 |
ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection
| ng/G creatinine | ORAL ANTIOXIDANT | Placebo |
|---|---|---|
| Systemic Oxidative Stress | 2.92 ± 1.99 | 2.09 ± 1.12 |
High Sensitivity CRP (nmol/L)
| nmol/L | ORAL ANTIOXIDANT | Placebo |
|---|---|---|
| Inflammation | 17.51 ± 20.19 | 16.95 ± 18.38 |
Collected over At each subject visit adverse events were reviewed with the subject.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ORAL ANTIOXIDANT | — | 1/22 (4.5%) | 18/22 (81.8%) |
| Placebo | — | 1/22 (4.5%) | 21/22 (95.5%) |
| Event | ORAL ANTIOXIDANT | Placebo |
|---|---|---|
| DeathNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/22 | 1/22 |
| Suicide AttemptPsychiatric disorders | 1/22 | 0/22 |
| Event | ORAL ANTIOXIDANT | Placebo |
|---|---|---|
| Non-Serious Adverse EventsGeneral disorders | 18/22 | 21/22 |
| Age, Categorical(Participants) | ORAL ANTIOXIDANT | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 22 | 44 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | ORAL ANTIOXIDANT | Placebo | Total |
|---|---|---|---|
| Mean | 44 ± 12 | 47 ± 10 | 46 ± 11 |
| Sex: Female, Male(Participants) | ORAL ANTIOXIDANT | Placebo | Total |
|---|---|---|---|
| Female | 9 | 4 | 13 |
| Male | 13 | 18 | 31 |
| Region of Enrollment(participants) | ORAL ANTIOXIDANT | Placebo | Total |
|---|---|---|---|
| United States | 22 | 22 | 44 |
Plan to share: No
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University of Michigan