Phase 3
N=44
An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
Diabetic Autonomic Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT00116207 ↗Enrolled (actual)
44
Serious AEs
4.6%
Results posted
Jan 2016
Primary outcome: Primary: Global [11C]HED Retention Index (RI) — 0.081; 0.073; 0.070; 0.074 Retention index — p=0.32
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ORAL ANTIOXIDANT (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global [11C]HED Retention Index (RI) |
0.081; 0.073; 0.070; 0.074 | 0.32 |
| SECONDARY Global Coronary Flow Reserve as a Measure of Endothelial Function |
2.95; 2.94; 3.02; 3.22 | 0.52 |
| SECONDARY Systemic Oxidative Stress |
2.92; 2.09 | 0.24 |
| SECONDARY Inflammation |
17.51; 16.95 | 0.83 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00116207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.