NCT00726713

Brief Summary

The purpose of this research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be randomly assigned to receive either Metanx or placebo for 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2008

Typical duration for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 30, 2013

Completed
Last Updated

August 30, 2013

Status Verified

July 1, 2013

Enrollment Period

1.9 years

First QC Date

July 30, 2008

Results QC Date

May 2, 2013

Last Update Submit

July 26, 2013

Conditions

Type 2 Diabetic Peripheral Neuropathy (DPN)

Keywords

Metanxdiabetesneuropathyfolic acidfolateL-methylfolatevitamin B6Pyridoxal 5'-phosphatevitamin B12methylcobalamin

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Vibration Perception Threshold (VPT) at 24 Weeks

    Vibration Perception Threshold (VPT) 25-45 volts at hallux on either leg as measured by VPT meter on the great toe of each foot. Mean VPT averaged across both toes.

    VPT was measured a 0 (baseline), and 24 weeks

Secondary Outcomes (10)

  • Change From Baseline in Neuropathy Total Symptom Score-6 (NTSS-6)

    NTSS-6 scores were taken at 0 (Baseline), 16, and 24 weeks

  • Change From Baseline in Neuropathy Disability Score (NDS)at Week 16 and 24

    NDS scores were taken at 0 (Baseline), 16, and 24 weeks

  • Change From Baseline in Plasma Marker Levels of Total Folate and Total Methyl Malonic Acid (MMA) at Week 16 and 24

    Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks

  • Change From Baseline in SF-36 MCS and SF-36 PCS at Week 24

    SF-36 MCS and SF-36 PCS scores were measured at 0 (Baseline) and 24 weeks

  • Change From Baseline in 10-point Visual Analog Scale(VAS) at Week 24

    VAS scores were taken at 0 (Baseline) and 24 weeks

  • +5 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Metanx

Other: Metanx (a medical food)

2

PLACEBO COMPARATOR

Placebo

Other: Metanx placebo

Interventions

Metanx (a medical food)OTHER

Metanx one tablet twice a day

1
Metanx placeboOTHER

Metanx placebo one tablet twice a day

2

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female between 25 and 80 years of age (inclusive);
  • Documented diabetes mellitus Type 2 (Based upon ADA criteria);
  • Peripheral polyneuropathy: Vibration Perception Threshold (VPT) 25-45 Volts at hallux on either leg.
  • Adequate lower extremity vascular status:
  • Palpable pedal pulse in both feet;
  • No intermittent claudication;
  • No history of lower extremity vascular bypass surgery or angioplasty
  • The subject is able to understand the information in the informed consent form and is willing and able to sign the consent.

You may not qualify if:

  • Amputation of any kind or an ulceration within the last two (2) years including at Screen;
  • History or active Charcot neuroarthropathy on either foot;
  • Previous surgery to spine or lower extremity with residual symptoms of pain or difficulty with movement;
  • Severe rheumatoid arthritis or osteoarthritis that would cause discomfort during causal walking or stair climbing;
  • Current treatment with systemic steroids, immunosuppressives, or radiotherapy;
  • Peripheral vascular disease defined as any nonpalpable foot pulse, history of claudication, or a history of lower extremity vascular bypass surgery or angioplasty;
  • Glycated hemoglobin (HbA1c) \>9 at Screen.
  • Uncontrolled heart (Hypertension: BP \> 160/90), or lung disease (uncontrolled asthma or shortness of breath) in the last 2 months prior to Screen;
  • End stage kidney disorder requiring hemodialysis or serum creatinine \> 2.5X (normal upper limit);
  • The following supplements within 2 months prior to Screen: alpha lipoic acid; B12 injection; \>10mg of B6; or, \> 800mcg of folate;
  • Taking either an opiate at any dose or on the maximum dose of any anticonvulsant;
  • Pregnant or nursing;
  • Life expectancy \< 12 months;
  • Initiated therapies for Painful Diabetic Neuropathy (pregabalin, gabapentin, duloxetine etc.) in the last 2 months prior to Screen;
  • Initiated new hyperglycemic, insulin, statin or hypertensive therapies within 2 months prior to Screen (dose modifications of current therapies are allowed at the discretion of the investigator);
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, 35294, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Omaha VA Medical Center

Omaha, Nebraska, 68105, United States

Location

Dallas Diabetes and Endocrine Center

Dallas, Texas, 75230, United States

Location

dgd Research, Inc.

San Antonio, Texas, 78229, United States

Location

Scott and White Hospital & Clinic

Temple, Texas, 76504, United States

Location

Related Publications (1)

  • Fonseca VA, Lavery LA, Thethi TK, Daoud Y, DeSouza C, Ovalle F, Denham DS, Bottiglieri T, Sheehan P, Rosenstock J. Metanx in type 2 diabetes with peripheral neuropathy: a randomized trial. Am J Med. 2013 Feb;126(2):141-9. doi: 10.1016/j.amjmed.2012.06.022. Epub 2012 Dec 5.

    PMID: 23218892RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

metanx

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

Adverse Event reporting detailed in the "Other Adverse Events" section was provided only with specificity to the affected Organ System. Additional detail for the "Other Adverse Events" was not available at the time of reporting.

Results Point of Contact

Title
Page Young, Clinical Project Manager
Organization
Pamlab Inc.
pyoung@pamlab.com
985-867-5788

Study Officials

  • Vivian Fonseca, MD

    Tulane University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2008

First Posted

August 1, 2008

Study Start

June 1, 2008

Primary Completion

May 1, 2010

Study Completion

June 1, 2011

Last Updated

August 30, 2013

Results First Posted

August 30, 2013

Record last verified: 2013-07

Locations

US(6)