Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)
NCT ID: NCT00726713
Last Updated: 2013-08-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
214 participants
INTERVENTIONAL
2008-06-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Metanx
Metanx (a medical food)
Metanx one tablet twice a day
2
Placebo
Metanx placebo
Metanx placebo one tablet twice a day
Interventions
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Metanx (a medical food)
Metanx one tablet twice a day
Metanx placebo
Metanx placebo one tablet twice a day
Eligibility Criteria
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Inclusion Criteria
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
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.
25 Years
80 Years
ALL
No
Sponsors
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Tulane University Health Sciences Center
OTHER
VA Nebraska Western Iowa Health Care System
FED
Scott and White Hospital & Clinic
OTHER
Dallas Diabetes and Endocrine Center
OTHER
University of Alabama at Birmingham
OTHER
dgd Research, Inc.
INDUSTRY
Baylor Health Care System
OTHER
Pamlab, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Vivian Fonseca, MD
Role: PRINCIPAL_INVESTIGATOR
Tulane University Health Sciences Center
Locations
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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
dgd Research, Inc.
San Antonio, Texas, United States
Scott and White Hospital & Clinic
Temple, Texas, United States
Countries
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References
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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.
Other Identifiers
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M-001
Identifier Type: -
Identifier Source: org_study_id