Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy
Primary Purpose
Peripheral Neuropathy, Diabetes Mellitus, Diabetes Complications
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thiamine
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathy focused on measuring Diabetic Peripheral Neuropathy, Peripheral Neuropathy, Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: Diagnosis of Diabetes Mellitus Painful diabetic neuropathy for > six months with a score of >40mm on a visual pain analog scale Age >18 years Hemoglobin A1c obtained within the last 3 months. Willingness and ability to comply with the study requirements and give informed consent. Exclusion Criteria: Known history of alcohol abuse, recreational drug abuse, thyroid dysfunction, syphilis, multiple myeloma, known nutrient deficiency, history of gastric bypass surgery or HIV. Hgb A1c>11
Sites / Locations
- Loma Linda University Department of Neurology
Outcomes
Primary Outcome Measures
Daily pain evaluations on a visual analog pain scale
Secondary Outcome Measures
Pain over the last 7 days as recorded on a Visual Analog pain scale
Changes in Sf-36v2 results
Changes in blood thiamine levels
Changes in the McGill short form pain questionnaire
Changes in sleep disturbance in secondary to pain as rated by a visual analog scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00279266
Brief Title
Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy
Official Title
A Randomized Double Blinded Pilot Study of Oral Thiamine in the Symptomatic Treatment of Painful Diabetic Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
inadequate recruitment
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will examine the effect of oral thiamine (Vitamin B1) supplementation on pain in patients with diabetic peripheral neuropathy.
Detailed Description
It is estimated that more then 5 million people in the United States suffer from Diabetes Mellitus, and of these up to 80% suffer from painful diabetic peripheral neuropathy. Multiple medications have been tried for the treatment of painful diabetic neuropathy. These medications are directed at symptomatic relief and do not address the underlying cause of painful peripheral neuropathy. Thiamine is a water-soluble vitamin that participates in carbohydrate metabolism. Deficiency of thiamine causes beriberi, characterized by painful peripheral neuropathy and cardiomyopathy. Basic research has suggested that thiamine deficiency may also be involved in the etiology of diabetic neuropathy by preventing the glycation of nerve fibers as well as apoptosis of endothelial cells. A study in the developing world found that oral thiamine and pyridoxine were helpful in improving the pain experienced in diabetic peripheral neuropathy as well as improving signs of neuropathy seen on neurological examination. A screening study of patients with type II diabetes found that 76% of patients tested had a low serum thiamine level.
Our study will examine the effect of oral thiamine supplementation on the symptom of pain in painful diabetic peripheral neuropathy. In addition we will follow serum thiamine levels to see if clinical change correlates with changes in serum thiamine levels
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Diabetes Mellitus, Diabetes Complications
Keywords
Diabetic Peripheral Neuropathy, Peripheral Neuropathy, Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Thiamine
Primary Outcome Measure Information:
Title
Daily pain evaluations on a visual analog pain scale
Secondary Outcome Measure Information:
Title
Pain over the last 7 days as recorded on a Visual Analog pain scale
Title
Changes in Sf-36v2 results
Title
Changes in blood thiamine levels
Title
Changes in the McGill short form pain questionnaire
Title
Changes in sleep disturbance in secondary to pain as rated by a visual analog scale
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Diabetes Mellitus Painful diabetic neuropathy for > six months with a score of >40mm on a visual pain analog scale Age >18 years Hemoglobin A1c obtained within the last 3 months. Willingness and ability to comply with the study requirements and give informed consent.
Exclusion Criteria:
Known history of alcohol abuse, recreational drug abuse, thyroid dysfunction, syphilis, multiple myeloma, known nutrient deficiency, history of gastric bypass surgery or HIV. Hgb A1c>11
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodolfo Escutin, MD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Department of Neurology
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12198817
Citation
Thornalley PJ. Glycation in diabetic neuropathy: characteristics, consequences, causes, and therapeutic options. Int Rev Neurobiol. 2002;50:37-57. doi: 10.1016/s0074-7742(02)50072-6.
Results Reference
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PubMed Identifier
9557427
Citation
Abbas ZG, Swai AB. Evaluation of the efficacy of thiamine and pyridoxine in the treatment of symptomatic diabetic peripheral neuropathy. East Afr Med J. 1997 Dec;74(12):803-8.
Results Reference
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Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy
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