An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

Phase 3 Completed 44 enrolled University of Michigan Juvenile Diabetes Research Foundation · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2000-01
Primary completion: 2009-09
Completion: 2009-12

Outcome

Missed primary endpoint

paper worsening of the global [(11)C]HED left ventricle RI (-0.010 [95% CI -0.020, -0.001] p = 0.045) PMID 23740194 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Allopurinol	Small molecule	300 mg	Oral
Subject	Nicotinamide	Other / unclassified	750 mg	Oral
Subject	α-lipoic acid	Unknown	600 mg	Oral