Oral Thiamine for the Treatment of Painful Diabetic Perip... | NCT00279266

Studies
Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy

NCT00279266

Sponsor

Loma Linda University

Status

Withdrawn

Last Update Posted

May 13, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Peripheral Neuropathy
Diabetes Mellitus
Diabetes Complications

Interventions

Thiamine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inadequate recruitment

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Jan 18, 2006

First Submission Date that Met QC Criteria

Jan 18, 2006

First Posted Date

Jan 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2015

Last Update Posted Date

May 13, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Travis Losey, Assistant Professor of Neurology, Loma Linda UniversityPrincipal Investigator

Lead Sponsor

Loma Linda UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Thiamine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Daily pain evaluations on a visual analog pain scale

Secondary Outcomes

Measure	Description	Time Frame
Pain over the last 7 days as recorded on a Visual Analog pain scale
Changes in Sf-36v2 results
Changes in blood thiamine levels

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rodolfo Escutin, MD	Loma Linda University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Loma Linda University Department of Neurology		Loma Linda	California	92354	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12198817	Background	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.
9557427	Background	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.

ID	Term
D010523	Peripheral Nervous System Diseases
D003920	Diabetes Mellitus
D048909	Diabetes Complications

ID	Term
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles