DiabetesSLHN2011-18NCT01503892
Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics
A study testing Metanx in people with Diabetes and Peripheral Neuropathy, run by St. Luke's Hospital and Health Network, Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Peripheral Neuropathy
- What is being tested?
- Metanx
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 Diabetics
- Pre-diabetics
- Symptoms of peripheral neuropathy
Who cannot join
- Pregnancy
- Under age 18
- HIV (+)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015
Edwin S. Hart III, DPM, 610-868-4300, ehart@footmed.com
About this study
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.
- Conditions
- Diabetes, Peripheral Neuropathy
- Being tested
- Metanx, Placebo
- Keywords
- Small Fiber Neuropathy, Metanx Effect on Small Fiber Neuropathy, Metanx Effect on Diabetic Peripheral Neuropathy
- Medical subject headings
- Diabetes Mellitus, Peripheral Nervous System Diseases, Small Fiber Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetanxDietary supplement
Metanx- one tablet twice daily for twelve months
PlaceboDrug
Placebo- one tablet twice daily for twelve months.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The control group will receive placebo pill twice daily for twelve months. Receives: Drug: Placebo |
| Metanx | Active comparator | Metanx group will receive one pill twice daily for twelve months. Receives: Dietary Supplement: Metanx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
Subjective improvement
Improvement in the subjective score versus the placebo group.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital and Health Network, Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Goldfarb Foundation, Pamlab, L.L.C.
- Responsible party
- Principal investigator, Edwin S. Hart III, St. Luke's Hospital and Health Network, Pennsylvania
- Investigators
- Edwin S. Hart III, DPM, Principal investigator, St. Luke's Hospital and Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503892
- Sponsor's protocol ID
- StLukeHHN
- Acronym
- SLHN2011-18
- Status last verified
- Jul 2012
- First submitted
- 29 Dec 2011
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics
- ClinicalTrials.gov ID
- NCT01503892
- Acronym / sponsor ID
- SLHN2011-18 / StLukeHHN
- Conditions
- Diabetes, Peripheral Neuropathy
- Keywords
- Small Fiber Neuropathy, Metanx Effect on Small Fiber Neuropathy, Metanx Effect on Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Luke's Hospital and Health Network, PennsylvaniaUniversity, hospital or other
- Collaborators
- Goldfarb Foundation, Pamlab, L.L.C.
- Study start
- Dec 2011
- Primary completion
- Oct 2013 (estimated)
- First posted
- 4 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe control group will receive placebo pill twice daily for twelve months. |
| Metanx | Active comparator | Dietary Supplement: MetanxMetanx group will receive one pill twice daily for twelve months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 Diabetics
- Pre-diabetics
- Symptoms of peripheral neuropathy
Key exclusion criteria (3 listed)
- Pregnancy
- Under age 18
- HIV (+)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetanxMetanx- one tablet twice daily for twelve months | Dietary supplement | Metanx |
| PlaceboPlacebo- one tablet twice daily for twelve months. | Drug | Placebo |
Primary outcome
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 secondary outcome
Subjective improvement
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
- William L. Goldfarb Educational Foundation for Research and Teaching of the Lower ExtremityLink provided by the sponsor.
- St. Luke's Hospital and Health NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin S. Hart III, DPM principal investigator
St. Luke's Hospital and Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metanx in people with Diabetes and Peripheral Neuropathy, run by St. Luke's Hospital and Health Network, Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edwin S. Hart III, DPM (610-868-4300, ehart@footmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased intraepidermal nerve fiber density (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012.