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

Pamlab, Inc.214 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

214

Conditions

Type 2 Diabetic Peripheral Neuropathy (DPN)

Interventions

Metanx (a medical food)OTHER

Metanx one tablet twice a day

Metanx placeboOTHER

Metanx placebo one tablet twice a day

Eligibility

Sex: ALLMin age: 25 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female between 25 and 80 years of age (inclusive); 2. Documented diabetes mellitus Type 2 (Based upon ADA criteria); 3. Peripheral polyneuropathy: Vibration Perception Threshold (VPT) 25-45 Volts at hallux on either leg. 4. Adequate lower extremity vascular status: * Palpable pedal pulse in both feet; * No intermittent claudication; * No history of lower extremity vascular bypass surgery or angioplasty 5. The subject is able to understand the information in the informed consent form and is willing and able to sign the consent. Exclusion Criteria: 1. Amputation of any kind or an ulceration within the last two (2) years including at Screen; 2. History or active Charcot neuroarthropathy on either foot; 3. Previous surgery to spine or lower extremity with residual symptoms of pain or difficulty with movement; 4. Severe rheumatoid arthritis or osteoarthritis that would cause discomfort during causal walking or stair climbing; 5. Current treatment with systemic steroids, immunosuppressives, or radiotherapy; 6. Peripheral vascular disease defined as any nonpalpable foot pulse, history of claudication, or a history of lower extremity vascular bypass surgery or angioplasty; 7. Glycated hemoglobin (HbA1c) \>9 at Screen. 8. Uncontrolled heart (Hypertension: BP \> 160/90), or lung disease (uncontrolled asthma or shortness of breath) in the last 2 months prior to Screen; 9. End stage kidney disorder requiring hemodialysis or serum creatinine \> 2.5X (normal upper limit); 10. The following supplements within 2 months prior to Screen: alpha lipoic acid; B12 injection; \>10mg of B6; or, \> 800mcg of folate; 11. Taking either an opiate at any dose or on the maximum dose of any anticonvulsant; 12. Pregnant or nursing; 13. Life expectancy \< 12 months; 14. Initiated therapies for Painful Diabetic Neuropathy (pregabalin, gabapentin, duloxetine etc.) in the last 2 months prior to Screen; 15. 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); 16. Current alcohol or drug abuse (or history of such abuse within the past 3 years); and, 17. Not willing or able to follow procedures specified by the protocol and/or the instructions of the study personnel.

Locations (6)

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Omaha VA Medical Center

Omaha, Nebraska, United States

Dallas Diabetes and Endocrine Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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

This measure was taken to determine if Metanx® (compared to placebo) changes neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6) The Neuropathy Total Symptom Score-6 Scale (NTSS-6) is a validated scale that evaluates individual neuropathy sensory symptoms in patients with diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN). This scale was a modified 6 item scale that consists of yes or no questions. Scores range between 0 and 21.96, a higher score indicates greater severity of symptoms. After adjusting for baseline measurements scores are reflected as negative numbers. Negative numbers indicate improvement in symptoms. ie. a change from baseline after 24 weeks of -2 would be a greater improvement than a change in baseline of -1 after 24 weeks.

Time frame: 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

This outcome was taken to determine if Metanx® (compared to placebo) has an effect on clinical examination as determined by the Neuropathy Disability Score (NDS) The Neuropathy Disability Score (NDS) evaluates the severity of individual symptoms of neuropathy. A simple visual numeric distress scale is used that ranges from 0 to 10. The most favorable score is 0, which indicates an absence of symptoms. The most severe symptoms possible would be recorded as a score of 10.

Time frame: 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

To determine if Metanx® (compared to placebo) affects a change in subject's total folate and total methyl malonic acid (MMA) at week 16 and 24

Data from ClinicalTrials.gov

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