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

Randomized, double-blind, placebo-controlled pilot study; 40 adults with type 2 diabetes and persistent microalbuminuria (21 men, 19 women); recruited at Sheikh Zayed Hospital, Lahore, Pakistan; central randomization; blinded participants, caregivers, and outcome assessors.

Thiamine, 3×100 mg capsules daily for 3 months, taken orally.

Thiamine reduced urinary albumin excretion (UAE) compared with baseline and placebo: post-treatment UAE medians were 30.1 mg/24 h (thiamine) vs 35.5 mg/24 h (placebo) (p<0.01); baseline UAE 43.7 mg/24 h vs 50.9 mg/24 h (p<0.001); relative decrease of 17.7 mg/24 h (p<0.001). Regression to normal UAE occurred in 35% of treated patients. No effects on glycemic control, dyslipidaemia or blood pressure; no adverse effects observed. During washout, UAE decreased further in both groups with no significant between-group differences. Authors conclude high-dose thiamine may reverse early-stage diabetic nephropathy and warrant further studies.

Small single-center pilot study; short duration; limited generalizability; not powered for long-term renal outcomes.