Effect of sulodexide on urinary biomarkers of kidney injury in normoalbuminuric type 2 diabetes: a randomized controlled trial.
Glycosaminoglycans or sulodexide has shown benefits in early experimental diabetic nephropathy (DN) models, but its efficacy in patients with early stage of DN is unknown. Methods. Twenty patients were randomly assigned to the placebo group and another 20 patients were randomly assigned to receive sulodexide 100 mg/day for 14 weeks. Primary outcome was a change of urinary TGF-beta1, albuminuria, and glomerular filtration rate (GFR). All patients had stable metabolic profiles for at least 90 days before randomization. Results. Urinary TGF-beta1 increased significantly in the placebo group but did not change significantly in the sulodexide group. Additionally, the mean change of urine TGF-beta1 in the placebo group was significantly higher than that in the sulodexide group (8.44 ± 9.21 versus 2.17 ± 6.96 pg/mg Cr, P = 0.02). Mean changes of urinary albumin were 15.05 ± 30.09 μg/mg Cr (P = 0.038) in the placebo group and 13.89 ± 32.25 μg/mg Cr (P = 0.069) in the sulodexide group. No consistent patterns of side effects were observed. Conclusion. In this 14-week trial, benefits of sulodexide in preventing the increase of urinary TGF-beta1 were observed in patients with normoalbuminuric type 2 diabetes. The study suggests that sulodexide treatment may provide additional renoprotection in early stage DN. This trial is registered with TCTR20140806001.
Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.
Bancha
B
Satirapoj
Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.
Wisit
W
Kaewput
Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.
Ouppatham
O
Supasyndh
Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.
Prajej
P
Ruangkanchanasetr
D000368:Aged; D000418:Albumins / Q000032:analysis; D000419:Albuminuria; D015415:Biomarkers / Q000652:urine*; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000652:urine*; D003928:Diabetic Nephropathies / Q000188:drug therapy; D005260:Female; D005919:Glomerular Filtration Rate; D006025:Glycosaminoglycans / Q000494:pharmacology*; D006801:Humans; D007004:Hypoglycemic Agents / Q000494:pharmacology / Q000627:therapeutic use; D007668:Kidney / Q000293:injuries*; D007674:Kidney Diseases / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D053773:Transforming Growth Factor beta1 / Q000652:urine; D016896:Treatment Outcome
D000418:Albumins; D015415:Biomarkers; D006025:Glycosaminoglycans; D007004:Hypoglycemic Agents; C508960:TGFB1 protein, human; D053773:Transforming Growth Factor beta1; C007858:glucuronyl glucosamine glycan sulfate