An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

Phase 3

Completed

• Conditions: Diabetic Autonomic Neuropathy
• Interventions: Drug: ORAL ANTIOXIDANT

• Registration Number: NCT00116207
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2005-06-27
• Study First Submitted QC: 2005-06-27
• Study First Posted: 2005-06-28
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Results First Submitted: 2014-01-06
• Results First Submitted QC: 2015-11-30
• Results First Posted: 2016-01-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-30
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORAL ANTIOXIDANT	ORAL ANTIOXIDANT	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	ORAL ANTIOXIDANT	Placebo administered twice daily.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Systemic Oxidative Stress	24 months	ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection
Inflammation	24 months	High Sensitivity CRP (nmol/L)

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States