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Randomized Controlled Trial
. 2009 Feb;52(2):208-12.
doi: 10.1007/s00125-008-1224-4. Epub 2008 Dec 5.

High-dose thiamine therapy for patients with type 2 diabetes and microalbuminuria: a randomised, double-blind placebo-controlled pilot study

N Rabbani  1 , S S Alam, S Riaz, J R Larkin, M W Akhtar, T Shafi, P J Thornalley
Affiliations
Randomized Controlled Trial

High-dose thiamine therapy for patients with type 2 diabetes and microalbuminuria: a randomised, double-blind placebo-controlled pilot study

N Rabbani et al. Diabetologia. 2009 Feb.

Abstract

Aims/hypothesis: 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/interpretation: 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.

Trial registration: CTRI (India) CTRI/2008/091/000112.

Funding: Pakistan Higher Education Commission.

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Comment in

  • Thiamine in diabetic nephropathy: a novel treatment modality?
    Alkhalaf A, Kleefstra N, Groenier KH, Bakker SJ, Navis GJ, Bilo HJ. Alkhalaf A, et al. Diabetologia. 2009 Jun;52(6):1212-3; author reply 1214-6. doi: 10.1007/s00125-009-1326-7. Epub 2009 Mar 19. Diabetologia. 2009. PMID: 19296076 No abstract available.

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