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

July 16, 2012 updated by: Edwin S. Hart III, St. Luke's Hospital and Health Network, Pennsylvania
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Luke's Hospital and Health Network
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Under age 18
  • HIV (+)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective improvement
Time Frame: 1 year
Improvement in the subjective score versus the placebo group.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's Hospital and Health Network, Pennsylvania

Collaborators

Pamlab, L.L.C.
Goldfarb Foundation

Investigators

  • Principal Investigator: Edwin S. Hart III, DPM, St. Luke's Hospital and Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ANTICIPATED)

October 1, 2013

Study Registration Dates

First Submitted

December 29, 2011

First Submitted That Met QC Criteria

December 31, 2011

First Posted (ESTIMATE)

January 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StLukeHHN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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