Study of Metanx® in Subjects With Type 2 Diabetic Peri...

Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)

Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)
This study is currently recruiting participants.
Verified by Pamlab, L.L.C., December 2008
Sponsors and Collaborators: Pamlab, L.L.C.
Tulane University Health Sciences Center
Omaha VA Medical Center
Scott and White Hospital & Clinic
Dallas Diabetes and Endocrine Center
Emory University
University of Alabama at Birmingham School of Medicine
Baylor University

Information provided by: Pamlab, L.L.C.
ClinicalTrials.gov Identifier: NCT00726713

Purpose
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.

Condition Intervention Phase
Type 2 Diabetic Peripheral Neuropathy (DPN)
Other: Metanx (a medical food)
Other: Metanx placebo
Phase IV

MedlinePlus related topics: Diabetes Peripheral Nerve Disorders
Drug Information available for: Folic acid Vitamin B 12 Hydroxocobalamin Vitamin B 6 5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride Pyridoxine Pyridoxal phosphate 5-Methyltetrahydrofolate Mecobalamin
U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:A 24 Week, Double-Blind, Placebo-Controlled, Multisite Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)

Further study details as provided by Pamlab, L.L.C.:

Primary Outcome Measures:
To determine if Metanx® (compared to placebo) improves sensory neuropathy in persons with Type 2 diabetes as measured by vibration perception threshold [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
To determine if Metanx® (compared to placebo) improves neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6) [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

To determine if Metanx® (compared to placebo) improves clinical examination as determined by the Neuropathy Disability Score (NDS) [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

To determine if Metanx® (compared to placebo) affects a subject's plasma markers levels by: a. Raising Folate, B6, & B12; b. Lowering methyl malonic acid (MMA); and, c. Lowering homocysteine (Hcy) [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

To determine if Metanx® (compared to placebo) affects a subject's "quality of life" as determined by the SF-36 questionnaire [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

To determine if Metanx® (compared to placebo) affects a subject's lower extremity pain level using a 10-point Visual Analog Scale at Baseline, 8, 16, and 24-week evaluation visits [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels by lowering hs-CRP, F2 Isoprostane, IL-6, TNF-á,and Urine Microalbumin and/or Urine Free Iron; and raising Potential Antioxidant (PAO) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

(Exploratory) Depression Evaluation: We will evaluate depression using the Hospital Anxiety and Depression Scale (HADS) question inventory at Baseline, 8, 16, and 24-week evaluation visits [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:216
Study Start Date:June 2008
Estimated Study Completion Date:December 2009
Estimated Primary Completion Date:December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Metanx Other: Metanx (a medical food)
Metanx one tablet twice a day
2: Placebo Comparator
Placebo Other: Metanx placebo
Metanx placebo one tablet twice a day

Eligibility
Ages Eligible for Study:25 Years to 80 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria
Inclusion Criteria:

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.
Exclusion Criteria:

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, immuno-suppressives, 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, gabapetin, duloxetine etc.) in the last 2 months prior to Screen;
Initiated new hyperglycemic, insulin, statin or hypertensive therapies within 2 months prior to Screen;
Current alcohol or drug abuse (or history of such abuse within the past 3 years); and,
Not willing or able to follow procedures specified by the protocol and/or the instructions of the study personnel.
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726713

Locations
United States, Alabama
University of Alabama at Birmingham School of Medicine Recruiting
Birmingham, Alabama, United States, 35294
Contact: Marianne Vetrano, RN 205-934-4112 mvetrano@uab.edu
Principal Investigator: Fernando Ovalle, MD
United States, Louisiana
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Patricia O Reilly, RN 504-988-4651 preilly@tulane.edu
Principal Investigator: Vivian A Fonseca, MD
United States, Nebraska
Omaha VA Medical Center Recruiting
Omaha, Nebraska, United States, 68105
Contact: Marlene Vogel, RN 402-995-4045 marlene.vogel@va.gov
Principal Investigator: Cyrus DeSouza, MD
United States, Texas
Scott and White Hospital & Clinic Recruiting
Temple, Texas, United States, 76504
Contact: Lori Murdoch, RN 254-771-7604 lmurdoch@swmail.sw.org
Principal Investigator: Lawrence A Lavery, DPM, MPH
Dallas Diabetes and Endocrine Center Recruiting
Dallas, Texas, United States, 75230
Contact: Lisa Mize, CCRC 972-566-2376 crc3@dallasdiabetes.com
Principal Investigator: Julio Rosenstock, MD

Sponsors and Collaborators
Pamlab, L.L.C.
Tulane University Health Sciences Center
Omaha VA Medical Center
Scott and White Hospital & Clinic
Dallas Diabetes and Endocrine Center
Emory University
University of Alabama at Birmingham School of Medicine
Baylor University
More Information

Responsible Party:Pamlab, LLC ( Harold Koch, Jr., Senior Vice President Business Development & Chief Scientific Officer )
Study ID Numbers:M-001
First Received:July 30, 2008
Last Updated:December 19, 2008
ClinicalTrials.gov Identifier:NCT00726713 [history]
Health Authority:United States: Institutional Review Board

Keywords provided by Pamlab, L.L.C.:
Metanx
diabetes
neuropathy
folic acid
folate
L-methylfolate
vitamin B6
Pyridoxal 5'-phosphate
vitamin B12
methylcobalamin

Study placed in the following topic categories:
Pyridoxal Phosphate
Diabetic Neuropathies
Hydroxocobalamin
Diabetes Mellitus
Endocrine System Diseases
Vitamin B 12
Vitamin B 6
Folic Acid
Neuromuscular Diseases
Peripheral Nervous System Diseases
Pyridoxine
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:
Nervous System Diseases