An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

This study is currently recruiting participants.

Verified by University of Michigan, April 2007

First Received: June 27, 2005 Last Updated: April 19, 2007 History of Changes

Sponsors and Collaborators:	University of Michigan Juvenile Diabetes Research Foundation
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00116207

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.

Condition	Intervention	Phase
Diabetic Autonomic Neuropathy	Drug: allopurinal, alpha lipoic acid (ALA), nicotinamide	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Niacin Thioctic Acid Niacinamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial

Further study details as provided by University of Michigan:

Primary Outcome Measures:

Retention Index (RI)

Secondary Outcome Measures:

Endothelial function
8-epi prostaglandin F2alpha
CRP
Adverse events

Estimated Enrollment:	50
Estimated Study Completion Date:	December 2008

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116207

Contacts

Contact: Cynthia Plunkett, RNC	734 936 8065	cplunket@umich.edu
Contact: Martha M Funnell, MS, RN	734 7635730	mfunnell@umich.edu

Locations

United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cynthia Plunkett, RNC 734-936-8065 cplunket@umich.edu
Contact: Martha M Funnell, MS, RN 734 7635730 mfunnell@umich.edu
Principal Investigator: Eva L Feldman, MD, PhD

Sponsors and Collaborators

University of Michigan

Juvenile Diabetes Research Foundation

Investigators

Principal Investigator:

Eva L Feldman, MD, PhD

University of Michigan

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	IRB:2002-0460
Study First Received:	June 27, 2005
Last Updated:	April 19, 2007
ClinicalTrials.gov Identifier:	NCT00116207 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Michigan:

Type 1 Diabetes
Oxidative Stress
Diabetic Complications
Neuropathy

Study placed in the following topic categories:

Antioxidants
Vitamin B Complex
Niacinamide
Diabetic Neuropathies
Diabetes Mellitus
Stress
Endocrine System Diseases
Trace Elements
Diabetes Mellitus Type 1
Nicotinic Acids

Diabetes Mellitus, Type 1
Neuromuscular Diseases
Vitamins
Peripheral Nervous System Diseases
Micronutrients
Endocrinopathy
Niacin
Diabetes Complications
Thioctic Acid

Additional relevant MeSH terms:

Antioxidants
Niacinamide
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Diabetic Neuropathies
Growth Substances
Physiological Effects of Drugs
Nervous System Diseases
Diabetes Mellitus

Endocrine System Diseases
Protective Agents
Pharmacologic Actions
Neuromuscular Diseases
Peripheral Nervous System Diseases
Vitamins
Micronutrients
Diabetes Complications
Thioctic Acid

ClinicalTrials.gov processed this record on May 07, 2009