The aim of the present study is to assess before, as well as 6 and 12 months following a therapy with benfotiamine the influence of therapy on intraepidermal nerve fiber density (skin biopsy) and neuropathic symptoms and deficits in people with type 1 or 2 diabetes mellitus and diabetic sensomotoric neuropathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
Treatment with 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
Treatment with placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
Diabetes Schwerpunktpraxis
Essen, North Rhine-Westphalia, Germany
Change from baseline in intraepidermal nerve fiber density
Time frame: 6 and 12 months
Change in neuropathic symptoms
Following questionnaires will be used to assess neuropathic symptoms: modified Toronto Clinical Neuropathy Score and Michigan Neuropathy Screening Instrument
Time frame: 3, 6 and 12 months
Change in neuropathic deficits
A score will be calculated at each timepoint using the Michigan Neuropathy Screening Instrument
Time frame: 3, 6 and 12 months
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