Expired Study
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Ann Arbor, Michigan 48109


Purpose:

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.


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


Study is Available At:


Original ID:

IRB:2002-0460


NCT ID:

NCT00116207


Secondary ID:


Study Acronym:


Brief Title:

An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes


Official Title:

Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

44


Enrollment Type:

Actual


Overall Contact Information

Official Name:Eva L Feldman, MD, PhD
Principal Investigator
University of Michigan

Study Dates

Start Date:January 2000
Completion Date:December 2009
Completion Type:Actual
Primary Completion Date:September 2009
Primary Completion Type:Actual
Verification Date:December 2013
Last Changed Date:December 18, 2013
First Received Date:June 27, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Adverse events
Time Frame:24 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:CRP
Time Frame:24 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:8-epi prostaglandin F2alpha
Time Frame:24 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Endothelial function
Time Frame:24 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Retention Index (RI)
Time Frame:24 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:ORAL ANTIOXIDANT
Description:Comparison of triple antioxidant therapy to placebo
Arm Name:ORAL ANTIOXIDANT
Other Name:Allopurinol (300mg daily),

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo administered twice daily.
Study Arm Type:Experimental
Arm Name:ORAL ANTIOXIDANT
Description:Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan
Agency Class:Other
Agency Type:Collaborator
Agency Name:Juvenile Diabetes Research Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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