Status:
COMPLETED
Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)
Lead Sponsor:
Pamlab, Inc.
Collaborating Sponsors:
Tulane University Health Sciences Center
VA Nebraska Western Iowa Health Care System
Conditions:
Type 2 Diabetic Peripheral Neuropathy (DPN)
Eligibility:
All Genders
25-80 years
Phase:
PHASE4
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 co...
Eligibility Criteria
Inclusion
- 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
- 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);
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00726713
Start Date
June 1 2008
End Date
June 1 2011
Last Update
August 30 2013
Active Locations (6)
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1
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, United States, 35294
2
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
3
Omaha VA Medical Center
Omaha, Nebraska, United States, 68105
4
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States, 75230