title: High-dose thiamine therapy for patients with type 2 diabetes and microalbuminuria: a randomised, double-blind placebo-controlled pilot study.
abstract: OBJECTIVE
  High-dose supplements of thiamine prevent the development of microalbuminuria in experimental diabetes. The aim of this pilot study was to assess whether oral supplements of thiamine could reverse microalbuminuria in patients with type 2 diabetes.
  
  
  METHODS
  Type 2 diabetic patients (21 male, 19 female) with microalbuminuria were recruited at the Diabetes Clinic, Sheikh Zayed Hospital, Lahore, Pakistan, and randomised to placebo and treatment arms. Randomisation was by central office in sequentially numbered opaque, sealed envelopes. Participants, caregivers and those assessing the outcomes were blinded to group assignment. Patients were given 3 x 100 mg capsules of thiamine or placebo per day for 3 months with a 2 month follow-up washout period. The primary endpoint was change in urinary albumin excretion (UAE). Other markers of renal and vascular dysfunction and plasma concentrations of thiamine were determined.
  
  
  RESULTS
  UAE was decreased in patients receiving thiamine therapy for 3 months with respect to baseline (median -17.7 mg/24 h; p < 0.001, n = 20). There was no significant decrease in UAE in patients receiving placebo after 3 months of therapy (n = 20). UAE was significantly lower in patients who had received thiamine therapy compared with those who had received placebo (30.1 vs 35.5 mg/24 h, p < 0.01) but not at baseline. UAE continued to decrease in the 2 month washout period in both groups, but not significantly. There was no effect of thiamine treatment on glycaemic control, dyslipidaemia or BP. There were no adverse effects of therapy.
  
  
  CONCLUSIONS
  In this pilot study, high-dose thiamine therapy produced a regression of UAE in type 2 diabetic patients with microalbuminuria. Thiamine supplements at high dose may provide improved therapy for early-stage diabetic nephropathy.
  
  
  BACKGROUND
  CTRI (India) CTRI/2008/091/000112.
  
  
  BACKGROUND
  Pakistan Higher Education Commission.
authors.affiliation: Clinical Sciences Research Institute, Warwick Medical School, University of Warwick, University Hospital, Clifford Bridge Road, Coventry CV2 2DX, UK.
authors.forename: N
authors.initials: N
authors.lastname: Rabbani
authors.forename: S S
authors.initials: SS
authors.lastname: Alam
authors.forename: S
authors.initials: S
authors.lastname: Riaz
authors.forename: J R
authors.initials: JR
authors.lastname: Larkin
authors.forename: M W
authors.initials: MW
authors.lastname: Akhtar
authors.forename: T
authors.initials: T
authors.lastname: Shafi
authors.forename: P J
authors.initials: PJ
authors.lastname: Thornalley
mesh_terms: D000419:Albuminuria / Q000517:prevention & control; D001794:Blood Pressure; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000652:urine; D004311:Double-Blind Method; D005919:Glomerular Filtration Rate; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D008055:Lipids / Q000097:blood; D010865:Pilot Projects; D010919:Placebos; D013831:Thiamine / Q000097:blood / Q000627:therapeutic use* / Q000652:urine
chemical_list: D006442:Glycated Hemoglobin; D008055:Lipids; D010919:Placebos; D013831:Thiamine