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Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics

NCT ID: NCT01503892

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Peripheral Neuropathy

Keywords

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Small Fiber Neuropathy Metanx Effect on Small Fiber Neuropathy Metanx Effect on Diabetic Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

The control group will receive placebo pill twice daily for twelve months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo- one tablet twice daily for twelve months.

Metanx

Metanx group will receive one pill twice daily for twelve months.

Group Type ACTIVE_COMPARATOR

Metanx

Intervention Type DIETARY_SUPPLEMENT

Metanx- one tablet twice daily for twelve months

Interventions

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Metanx

Metanx- one tablet twice daily for twelve months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo- one tablet twice daily for twelve months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
* Under age 18
* HIV (+)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Goldfarb Foundation

UNKNOWN

Sponsor Role collaborator

Pamlab, L.L.C.

INDUSTRY

Sponsor Role collaborator

St. Luke's Hospital and Health Network, Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Edwin S. Hart III

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edwin S. Hart III, DPM

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Hospital and Health Network

Locations

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St. Luke's Hospital and Health Network

Bethlehem, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Edwin S. Hart III, DPM

Role: CONTACT

Phone: 610-868-4300

Email: [email protected]

Facility Contacts

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Edwin S. Hart III, DPM

Role: primary

Related Links

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http://www.goldfarbfoundation.org/

William L. Goldfarb Educational Foundation for Research and Teaching of the Lower Extremity

http://www.mystlukesonline.org

St. Luke's Hospital and Health Network

Other Identifiers

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StLukeHHN

Identifier Type: -

Identifier Source: org_study_id