Not Signed In -
Alpha-Lipoic Acid |
dihydrolipoic acid; lipoic acid; lipolate; thiotic acid |
Clinical Trial: An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
This study is currently recruiting patients.
|
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: Combination of allopurinol, alpha lipoic acid (ALA), and nicotinamide | Phase III |
MedlinePlus related topics: Diabetic Nerve Problems
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:
Primary Outcomes: Retention Index (RI)
Secondary Outcomes: Endothelial function; 8-epi prostaglandin F2alpha; CRP; Adverse events
Expected Total Enrollment: 50
Secondary Outcomes: Endothelial function; 8-epi prostaglandin F2alpha; CRP; Adverse events
Expected Total Enrollment: 50
Expected completion: December 2007
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Type 1 diabetes
- A1C <9%
- Mild neuropathy
- Mild retinopathy
- Mild nephropathy
Exclusion Criteria:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00116207
Cynthia Plunkett, RNC 734 936 8065 cplunket@umich.edu
Martha M Funnell, MS, RN 734 7635730 mfunnell@umich.edu
Martha M Funnell, MS, RN 734 7635730 mfunnell@umich.edu
Michigan
University of Michigan, Ann Arbor, Michigan, 48109, United States; Recruiting
Cynthia Plunkett, RNC 734-936-8065 cplunket@umich.edu
Martha M Funnell, MS, RN 734 7635730 mfunnell@umich.edu
Eva L Feldman, MD, PhD, Principal Investigator
Martha M Funnell, MS, RN 734 7635730 mfunnell@umich.edu
Eva L Feldman, MD, PhD, Principal Investigator
More Information
Study ID Numbers: IRB:2002-0460
Record last reviewed: May 2005
Last Updated: June 30, 2005
Record first received: June 27, 2005
ClinicalTrials.gov Identifier: NCT00116207
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05
Record last reviewed: May 2005
Last Updated: June 30, 2005
Record first received: June 27, 2005
ClinicalTrials.gov Identifier: NCT00116207
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05
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