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

Diabet Med. 2013 Oct;30(10):1204-8. doi: 10.1111/dme.12240. Epub 2013 Jun 12.

Abstract

Aims: 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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antioxidants / therapeutic use*
  • Autonomic Pathways / drug effects*
  • Autonomic Pathways / physiopathology
  • Biomarkers / blood
  • Blood Glucose / metabolism
  • Cross-Over Studies
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / epidemiology
  • Diabetes Mellitus, Type 2 / physiopathology
  • Diabetic Neuropathies / blood
  • Diabetic Neuropathies / drug therapy*
  • Diabetic Neuropathies / epidemiology
  • Diabetic Neuropathies / physiopathology
  • Double-Blind Method
  • Endothelium, Vascular / drug effects*
  • Endothelium, Vascular / physiopathology
  • Fasting
  • Female
  • Humans
  • Laser-Doppler Flowmetry
  • Male
  • Microcirculation / drug effects
  • Middle Aged
  • Pilot Projects
  • Postprandial Period* / drug effects
  • Thiamine / analogs & derivatives*
  • Thiamine / therapeutic use

Substances

  • Antioxidants
  • Biomarkers
  • Blood Glucose
  • Thiamine
  • benphothiamine