An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

Diabetic Autonomic Neuropathy Clinical Trial

Official title:

Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116207
• Other study ID #: IRB:2002-0460
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2005
• Last updated: November 30, 2015
• Start date: January 2000
• Est. completion date: December 2009

Study information

• Verified date: November 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Autonomic Neuropathy
• Diabetic Neuropathies
• Nervous System Diseases

Intervention

Drug:
• ORAL ANTIOXIDANT
Comparison of triple antioxidant combination therapy vs placebo.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 24 months	No
Secondary	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.	Baseline, 24 months	No
Secondary	Systemic Oxidative Stress	ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection	24 months	No
Secondary	Inflammation	High Sensitivity CRP (nmol/L)	24 months	No