An Intervention Trial for Cardiac Neuropathy in Type 1 ...

An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
This study is currently recruiting participants.
Verified by University of Michigan, April 2007
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.
ress
Drug Information available for: Thioctic acid Niacin Niacin hydrochloride 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

Related Info

Study ID Numbers:IRB:2002-0460
First Received:June 27, 2005
Last Updated:April 19, 2007
ClinicalTrials.gov Identifier:NCT00116207 [history]
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:
Niacinamide
Diabetic Neuropathies
Diabetes Mellitus
Stress
Endocrine System Diseases
Nicotinic Acids
Diabetes Mellitus, Type 1
Neuromuscular Diseases
Peripheral Nervous System Diseases
Endocrinopathy
Niacin
Diabetes Complications
Thioctic Acid

Additional relevant MeSH terms:
Antioxidants
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins
Physiological Effects of Drugs
Nervous System Diseases
Micronutrients
Protective Agents
Pharmacologic Actions