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Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics (SLHN2011-18)

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ClinicalTrials.gov Identifier: NCT01503892
Recruitment Status : Unknown
Verified July 2012 by Edwin S. Hart III, St. Luke's Hospital and Health Network, Pennsylvania.
Recruitment status was:  Recruiting
First Posted : January 4, 2012
Last Update Posted : July 17, 2012
Sponsor:
Collaborators:
Goldfarb Foundation
Pamlab, L.L.C.
Information provided by (Responsible Party):
Edwin S. Hart III, St. Luke's Hospital and Health Network, Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Peripheral Neuropathy Dietary Supplement: Metanx Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics
Study Start Date : December 2011
Estimated Primary Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Mecobalamin

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
The control group will receive placebo pill twice daily for twelve months.
 Drug: Placebo
Placebo- one tablet twice daily for twelve months.
Active Comparator: Metanx
Metanx group will receive one pill twice daily for twelve months.
 Dietary Supplement: Metanx
Metanx- one tablet twice daily for twelve months


Outcome Measures
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Primary Outcome Measures :
  1. Increased intraepidermal nerve fiber density [ Time Frame: 1 year ]
    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


Secondary Outcome Measures :
  1. Subjective improvement [ Time Frame: 1 year ]
    Improvement in the subjective score versus the placebo group.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 Diabetics
  • Pre-diabetics
  • Symptoms of peripheral neuropathy

Exclusion Criteria:

  • Pregnancy
  • Under age 18
  • HIV (+)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503892


Contacts
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Contact: Edwin S. Hart III, DPM 610-868-4300 ehart@footmed.com

Locations
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United States, Pennsylvania
St. Luke's Hospital and Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Edwin S. Hart III, DPM    610-868-4300    ehart@footmed.com   
Sponsors and Collaborators
St. Luke's Hospital and Health Network, Pennsylvania
Goldfarb Foundation
Pamlab, L.L.C.
Investigators
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Principal Investigator: Edwin S. Hart III, DPM St. Luke's Hospital and Health Network
More Information
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Additional Information:
PamLab  This link exits the ClinicalTrials.gov site

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Responsible Party: Edwin S. Hart III, Principal Investigator, St. Luke's Hospital and Health Network, Pennsylvania
ClinicalTrials.gov Identifier: NCT01503892    
Other Study ID Numbers: StLukeHHN
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012
Keywords provided by Edwin S. Hart III, St. Luke's Hospital and Health Network, Pennsylvania:
Small Fiber Neuropathy
Metanx Effect on Small Fiber Neuropathy
Metanx Effect on Diabetic Peripheral Neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases