Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics
SLHN2011-18
1 other identifier
interventional
100
1 country
1
Brief Summary
This study focuses on the use of Metanx® as the sole treatment for improving and reversing nerve damage in type 2 diabetic patients with peripheral neuropathy. There will be two equal study groups enrolled in this randomized double blinded study. The minimum sample size of enrollment is 24 (12 per group), which is required for 90% power at alpha = .05. The maximum number of participants will be set at 100 (50 per group). Patients who are pre-diabetic or patients who have been diagnosed with diabetes type II for less than five years are included in this study. The control group will receive placebo pill twice daily versus the treatment group which will receive one Metanx® tablet twice daily. Each group will have intraepidermal nerve fiber densities obtained by skin biopsies taken at the beginning of the study before any treatment has begun as well as a final intraepidermal nerve skin biopsy at the end of twelve months to re-biopsy. In addition each group will answer three sets of questionnaires relating to their peripheral neuropathy at initial, three months, twelve month visitations. If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density and an improvement in the subjective score versus the placebo group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 29, 2011
CompletedFirst Posted
Study publicly available on registry
January 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedJuly 17, 2012
July 1, 2012
1.8 years
December 29, 2011
July 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increased intraepidermal nerve fiber density
If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density
1 year
Secondary Outcomes (1)
Subjective improvement
1 year
Study Arms (2)
Placebo
PLACEBO COMPARATORThe control group will receive placebo pill twice daily for twelve months.
Metanx
ACTIVE COMPARATORMetanx group will receive one pill twice daily for twelve months.
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 Diabetics
- Pre-diabetics
- Symptoms of peripheral neuropathy
You may not qualify if:
- Pregnancy
- Under age 18
- HIV (+)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Luke's Hospital and Health Network, Pennsylvanialead
- Goldfarb Foundationcollaborator
- Pamlab, L.L.C.collaborator
Study Sites (1)
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edwin S. Hart III, DPM
St. Luke's Hospital and Health Network
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 29, 2011
First Posted
January 4, 2012
Study Start
December 1, 2011
Primary Completion
October 1, 2013
Last Updated
July 17, 2012
Record last verified: 2012-07