An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

University of Michigan

Status and phase: Completed; Phase 3

Conditions: Diabetic Autonomic Neuropathy

Treatments: Drug: ORAL ANTIOXIDANT

Study type: Interventional

Funder types: Other

Identifiers

NCT00116207

IRB:2002-0460

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

ORAL ANTIOXIDANT

Experimental group

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.

Treatment:

Drug: ORAL ANTIOXIDANT

Placebo

Placebo Comparator group

Description:

Placebo administered twice daily.

Treatment:

Drug: ORAL ANTIOXIDANT