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Trial record 2 of 2 for:    "Autonomic Neuropathy" | "Nutrients"

An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT00116207
Recruitment Status : Completed
First Posted : June 28, 2005
Results First Posted : January 5, 2016
Last Update Posted : July 29, 2016
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Rodica Pop-Busui, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetic Autonomic Neuropathy
Intervention Drug: ORAL ANTIOXIDANT
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ORAL ANTIOXIDANT Placebo
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Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

Placebo administered twice daily.

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

Period Title: Overall Study
Started 22 22
Completed 13 18
Not Completed 9 4
Arm/Group Title ORAL ANTIOXIDANT Placebo Total
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Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

Placebo administered twice daily.

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
22
 100.0%
44
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 44 participants
44  (12) 47  (10) 46  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
9
  40.9%
4
  18.2%
13
  29.5%
Male
13
  59.1%
18
  81.8%
31
  70.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 44 participants
22 22 44
1.Primary Outcome
Title Global [11C]HED Retention Index (RI)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ORAL ANTIOXIDANT Placebo
Hide Arm/Group Description:

Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

Placebo administered twice daily.

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

Overall Number of Participants Analyzed 13 18
Mean (Standard Deviation)
Unit of Measure: Retention index
BASELINE 0.081  (0.017) 0.073  (0.016)
24 MONTHS 0.070  (0.018) 0.074  (0.016)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ORAL ANTIOXIDANT, Placebo
Comments BASELINE
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ORAL ANTIOXIDANT, Placebo
Comments 24-MONTH
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Global Coronary Flow Reserve as a Measure of Endothelial Function
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ORAL ANTIOXIDANT Placebo
Hide Arm/Group Description:

Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

Placebo administered twice daily.

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

Overall Number of Participants Analyzed 13 18
Mean (Standard Deviation)
Unit of Measure: ratio (rest:stress)
BASELINE 2.95  (1.32) 2.94  (1.70)
24 MONTH 3.02  (1.82) 3.22  (0.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ORAL ANTIOXIDANT, Placebo
Comments BASELINE
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ORAL ANTIOXIDANT, Placebo
Comments 24 MONTH
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Systemic Oxidative Stress
Hide Description ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ORAL ANTIOXIDANT Placebo
Hide Arm/Group Description:

Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

Placebo administered twice daily.

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

Overall Number of Participants Analyzed 13 18
Mean (Standard Deviation)
Unit of Measure: ng/G creatinine
2.92  (1.99) 2.09  (1.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ORAL ANTIOXIDANT, Placebo
Comments 24 MONTH
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments p values were computed using a general linear model adjusted at baseline for age, sex, HbA1c.
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Inflammation
Hide Description High Sensitivity CRP (nmol/L)
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ORAL ANTIOXIDANT Placebo
Hide Arm/Group Description:

Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

Placebo administered twice daily.

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

Overall Number of Participants Analyzed 13 18
Mean (Standard Deviation)
Unit of Measure: nmol/L
17.51  (20.19) 16.95  (18.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ORAL ANTIOXIDANT, Placebo
Comments 24 MONTH
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.
Method ANOVA
Comments [Not Specified]
Time Frame At each subject visit adverse events were reviewed with the subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ORAL ANTIOXIDANT Placebo
Hide Arm/Group Description

Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

Placebo administered twice daily.

ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo

All-Cause Mortality
ORAL ANTIOXIDANT Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ORAL ANTIOXIDANT Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/22 (4.55%)      1/22 (4.55%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Death  [1]  0/22 (0.00%)  0 1/22 (4.55%)  1
Psychiatric disorders     
Suicide Attempt   1/22 (4.55%)  1 0/22 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Liver cancer resulting in death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ORAL ANTIOXIDANT Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/22 (81.82%)      21/22 (95.45%)    
General disorders     
Non-Serious Adverse Events * [1]  18/22 (81.82%)  137 21/22 (95.45%)  141
*
Indicates events were collected by non-systematic assessment
[1]
General complaints or concerns reported by participants that were non-serious, and mild to moderate in nature
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eva L. Feldman, Professor of Internal Medicine
Organization: University of Michigan
Phone: 7347637274
EMail: efeldman@med.umich.edu
Layout table for additonal information
Responsible Party: Rodica Pop-Busui, University of Michigan
ClinicalTrials.gov Identifier: NCT00116207     History of Changes
Other Study ID Numbers: IRB:2002-0460
First Submitted: June 27, 2005
First Posted: June 28, 2005
Results First Submitted: January 6, 2014
Results First Posted: January 5, 2016
Last Update Posted: July 29, 2016