title: A randomized, double-blind, crossover, placebo-controlled trial of 6 weeks benfotiamine treatment on postprandial vascular function and variables of autonomic nerve function in Type 2 diabetes.
abstract: OBJECTIVE
  In a pilot study we suggested that benfotiamine, a thiamine prodrug, prevents postprandial endothelial dysfunction in people with Type 2 diabetes mellitus. The aim of this study was to test these effects in a larger population.
  
  
  METHODS
  In a double-blind, placebo-controlled, randomized, crossover study, 31 people with Type 2 diabetes received 900 mg/day benfotiamine or a placebo for 6 weeks (with a washout period of 6 weeks between). At the end of each treatment period, macrovascular and microvascular function were assessed, together with variables of autonomic nervous function in a fasting state, as well as 2, 4 and 6 h following a heated, mixed test meal.
  
  
  RESULTS
  Participants had an impaired baseline flow-mediated dilatation (2.63 ± 2.49%). Compared with the fasting state, neither variable changed postprandially following the placebo treatment. The 6 weeks' treatment with high doses of benfotiamine did not alter this pattern, either in the fasting state or postprandially. Among a subgroup of patients with the highest flow-mediated dilatation, following placebo treatment there was a significant postprandial flow-mediated dilatation decrease, while this effect was attenuated by benfotiamine pretreatment.
  
  
  CONCLUSIONS
  In people with Type 2 diabetes and markedly impaired fasting flow-mediated dilatation, a mixed test meal does not further deteriorate flow-mediated dilatation or variables of microvascular or autonomic nervous function. Because no significant deterioration of postprandial flow-mediated dilatation, microvascular or autonomic nervous function tests occurred after placebo treatment, a prevention of the postprandial deterioration of these variables with benfotiamine was not feasible.
authors.affiliation: Diabetes Clinic, Heart and Diabetes Center NRW, Bad Oeynhausen, Germany; Profil Institute for Metabolic Research GmbH, Neuss, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Stirban
authors.forename: A
authors.initials: A
authors.lastname: Pop
authors.forename: D
authors.initials: D
authors.lastname: Tschoepe
mesh_terms: D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000627:therapeutic use*; D017776:Autonomic Pathways / Q000187:drug effects* / Q000503:physiopathology; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D003929:Diabetic Neuropathies / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D004311:Double-Blind Method; D004730:Endothelium, Vascular / Q000187:drug effects* / Q000503:physiopathology; D005215:Fasting; D005260:Female; D006801:Humans; D017078:Laser-Doppler Flowmetry; D008297:Male; D008833:Microcirculation / Q000187:drug effects; D008875:Middle Aged; D010865:Pilot Projects; D019518:Postprandial Period / Q000187:drug effects; D013831:Thiamine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000975:Antioxidants; D015415:Biomarkers; D001786:Blood Glucose; D013831:Thiamine; C013835:benphothiamine