Trial · NCT00116207
An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
NCT00116207, Phase 3, Completed, University of Michigan; results first posted 2016-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes. Trials, record NCT00116207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00116207
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
- NCT number
- NCT00116207
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 44 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Diabetic Autonomic Neuropathy
- Interventions
- ORAL ANTIOXIDANT
- First posted
- 2005-06-28
- Last updated
- 2016-07-29
- Results first posted
- 2016-01-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Global [11C]HED Retention Index (RI) | 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 | Global Coronary Flow Reserve as a Measure of Endothelial Function | 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. |
| Secondary | Systemic Oxidative Stress | 24 months | ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection |
| Secondary | Inflammation | 24 months | High Sensitivity CRP (nmol/L) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Global [11C]HED Retention Index (RI) | Baseline, 24 months | Retention index | MEAN | |
| SECONDARY | Global Coronary Flow Reserve as a Measure of Endothelial Function | Baseline, 24 months | ratio (rest:stress) | MEAN | |
| SECONDARY | Systemic Oxidative Stress | 24 months | ng/G creatinine | MEAN | |
| SECONDARY | Inflammation | 24 months | nmol/L | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Global [11C]HED Retention Index (RI) | ORAL ANTIOXIDANT | BASELINE | 0.081 | Standard Deviation 0.017 | Retention index |
| Global [11C]HED Retention Index (RI) | Placebo | BASELINE | 0.073 | Standard Deviation 0.016 | Retention index |
| Global [11C]HED Retention Index (RI) | ORAL ANTIOXIDANT | 24 MONTHS | 0.070 | Standard Deviation 0.018 | Retention index |
| Global [11C]HED Retention Index (RI) | Placebo | 24 MONTHS | 0.074 | Standard Deviation 0.016 | Retention index |
| Global Coronary Flow Reserve as a Measure of Endothelial Function | ORAL ANTIOXIDANT | BASELINE | 2.95 | Standard Deviation 1.32 | ratio (rest:stress) |
| Global Coronary Flow Reserve as a Measure of Endothelial Function | Placebo | BASELINE | 2.94 | Standard Deviation 1.70 | ratio (rest:stress) |
| Global Coronary Flow Reserve as a Measure of Endothelial Function | ORAL ANTIOXIDANT | 24 MONTH | 3.02 | Standard Deviation 1.82 | ratio (rest:stress) |
| Global Coronary Flow Reserve as a Measure of Endothelial Function | Placebo | 24 MONTH | 3.22 | Standard Deviation 0.85 | ratio (rest:stress) |
| Systemic Oxidative Stress | ORAL ANTIOXIDANT | 2.92 | Standard Deviation 1.99 | ng/G creatinine | |
| Systemic Oxidative Stress | Placebo | 2.09 | Standard Deviation 1.12 | ng/G creatinine |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ORAL ANTIOXIDANT | 22 | |
| Overall Study | STARTED | Placebo | 22 | |
| Overall Study | COMPLETED | ORAL ANTIOXIDANT | 13 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | ORAL ANTIOXIDANT | 9 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Non-Serious Adverse Events | General disorders | ORAL ANTIOXIDANT | 18 | 22 | 137 |
| other | Non-Serious Adverse Events | General disorders | Placebo | 21 | 22 | 141 |
| serious | Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ORAL ANTIOXIDANT | 0 | 22 | 0 |
| serious | Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 1 | 22 | 1 |
| serious | Suicide Attempt | Psychiatric disorders | ORAL ANTIOXIDANT | 1 | 22 | 1 |
| serious | Suicide Attempt | Psychiatric disorders | Placebo | 0 | 22 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ORAL ANTIOXIDANT | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | ORAL ANTIOXIDANT | 18 | 22 |
| Total, other adverse events | Placebo | 21 | 22 |
| Total, serious adverse events | ORAL ANTIOXIDANT | 1 | 22 |
| Total, serious adverse events | Placebo | 1 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23740194 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ORAL ANTIOXIDANT vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00116207
GET https://conductscience.org/api/trials/v1/NCT00116207/registered