Abstract
Objective:
To investigate the effect of benfotiamine on urinary albumin excretion (UAE) and the tubular damage marker kidney injury molecule-1 (KIM-1) in patients with type 2 diabetes and nephropathy.
Research design and methods:
Patients with type 2 diabetes and UAE equivalent to 15-300 mg/24 h, despite ACE inhibitors (ACE-Is) or angiotensin receptor blockers (ARBs), were randomly assigned to 12 weeks of benfotiamine (900 mg/day) (n = 39) or placebo (n = 43).
Results:
Compared with placebo, benfotiamine treatment resulted in significant improvement of thiamine status (P < 0.001). Benfotiamine treatment did not significantly decrease 24-h UAE or 24-h KIM-1 excretion.
Conclusions:
In patients with type 2 diabetes and nephropathy, high-dose benfotiamine treatment for 12 weeks in addition to ACE-Is or ARBs did not reduce UAE or KIM-1 excretion, despite improvement of thiamine status.
Trial registration:
ClinicalTrials.gov NCT00565318.
Publication types
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adjuvants, Immunologic / administration & dosage*
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Adult
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Aged
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Albuminuria / drug therapy*
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Albuminuria / urine
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Angiotensin II Type 1 Receptor Blockers / therapeutic use
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Angiotensin-Converting Enzyme Inhibitors / therapeutic use
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Biomarkers / urine
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Diabetes Mellitus, Type 2 / drug therapy*
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Diabetes Mellitus, Type 2 / urine
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Diabetic Nephropathies / drug therapy*
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Diabetic Nephropathies / urine
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Double-Blind Method
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Drug Therapy, Combination
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Female
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Hepatitis A Virus Cellular Receptor 1
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Humans
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Kidney Tubules / drug effects
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Male
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Membrane Glycoproteins / urine
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Middle Aged
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Placebos
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Receptors, Virus
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Thiamine / administration & dosage
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Thiamine / analogs & derivatives*
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Thiamine / blood
Substances
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Adjuvants, Immunologic
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Angiotensin II Type 1 Receptor Blockers
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Angiotensin-Converting Enzyme Inhibitors
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Biomarkers
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HAVCR1 protein, human
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Hepatitis A Virus Cellular Receptor 1
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Membrane Glycoproteins
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Placebos
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Receptors, Virus
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Thiamine
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benphothiamine
Associated data
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ClinicalTrials.gov/NCT00565318