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High-dose thiamine [vitamin B1] therapy for patients with type 2 diabetes and microalbuminuria: A randomized, double-blind placebo-controlled pilot study – Source: Diabetologia, Dec 5, 2008

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By N Rabbini, PJ Thornalley, et al. • www.ProHealth.com • December 9, 2008


[Note: albuminuria is the presence of albumin (protein) in the urine and is an important marker for kidney disease. Normally functioning kidneys filter protein molecules out of the blood and keep it from entering the urine. Microalbuminuria refers to an early stage in this disorder. Diabetes and hypertension are the two most important risk factors.]

Aims/Hypothesis: High-dose supplements of thiamine [vitamin B1] 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 randomized to placebo and treatment arms. Randomization 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 glycemic control, dyslipidemia [high cholesterol] or blood pressure.

• 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.

Source: Diabetologia, Dec 5, 2008. [E-pub ahead of print] PMID: 19057893 by Rabbini N, Alam SS, Riaz S, Larkin JR, Akhtar MW, Shafi T, Thornalley PJ. Clinical Sciences Research Institute, Warwick Medical School, University of Warwick, University Hospital, Coventry, UK. [E-mail: P.J.Thornalley@warwick.ac.ukk]





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