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An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

Primary Purpose

Diabetic Autonomic Neuropathy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ORAL ANTIOXIDANT
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Autonomic Neuropathy focused on measuring Type 1 Diabetes, Oxidative Stress, Diabetic Complications, Neuropathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ORAL ANTIOXIDANT

Placebo

Arm Description

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 administered twice daily.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 27, 2005
Last Updated
June 30, 2016
Sponsor
University of Michigan
Collaborators
Juvenile Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00116207
Brief Title
An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
Official Title
Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Juvenile Diabetes Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Autonomic Neuropathy
Keywords
Type 1 Diabetes, Oxidative Stress, Diabetic Complications, Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ORAL ANTIOXIDANT
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered twice daily.
Intervention Type
Drug
Intervention Name(s)
ORAL ANTIOXIDANT
Other Intervention Name(s)
Allopurinol (300mg daily),, ALA (600mg twice daily), nicotinamide (750 mg twice daily)
Intervention Description
Comparison of triple antioxidant combination therapy vs placebo.
Primary Outcome Measure Information:
Title
Global [11C]HED Retention Index (RI)
Description
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.
Time Frame
Baseline, 24 months
Secondary Outcome Measure Information:
Title
Global Coronary Flow Reserve as a Measure of Endothelial Function
Description
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.
Time Frame
Baseline, 24 months
Title
Systemic Oxidative Stress
Description
ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection
Time Frame
24 months
Title
Inflammation
Description
High Sensitivity CRP (nmol/L)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva L Feldman, MD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23740194
Citation
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.
Results Reference
derived
Links:
URL
http://www.umich.edu/~jdrf
Description
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An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

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