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Effect of chelation therapy on progressive diabetic nephropathy in patients with type 2 diabetes and high-normal body lead burdens . BACKGROUND A previous study in type 2 diabetic patients with high-normal body lead burdens showed that EDTA chelation therapy for 3 months slows progressive diabetic nephropathy during a 12-month follow-up . The effect of a longer course of therapy on kidney function decrease over a longer follow-up is not known . STUDY DESIGN A 12-month run-in phase , then a randomized single-blind study with a 27-month intervention . SETTING & PARTICIPANTS University medical center ; 50 patients ( serum creatinine , 1.5-3.9 mg/dL ) with high-normal body lead burden ( ≥80- < 600 μg ) were randomly assigned to the treatment and control groups . INTERVENTION The treatment group received weekly chelation therapy for 3 months to reduce their body lead burden to < 60 μg and then as needed for 24 months to maintain this level . The control group received placebo for 3 months and then weekly for 5 weeks at 6-month intervals for 24 months . OUTCOMES The primary end point was change in estimated glomerular filtration rate ( eGFR ) over time . A secondary end point was a 2-fold increase in baseline serum creatinine level or the requirement for renal replacement therapy . MEASUREMENTS Body lead burdens were assessed by EDTA mobilization tests and eGFR was calculated using the equation for Chinese patients with type 2 diabetes . RESULTS Mean baseline eGFRs in the treatment and control groups were similar . After 3 months of chelation therapy , the change in eGFR in the treatment group ( +1.0 ± 4.8 mL/min/1.73 m ( 2 ) ) differed significantly from that in the control group ( -1.5 ± 4.8 mL/min/1.73 m ( 2 ) ; P = 0.04 ) . In the subsequent 24-month intervention , the yearly rate of decrease in eGFR ( 5.6 ± 5.0 mL/min/1.73 m ( 2 ) per year ) in the treatment group was slower than that ( 9.2 ± 3.6 mL/min/1.73 m ( 2 ) per year ; P = 0.04 ) in the control group . 17 ( 68 % ) control-group patients and 9 ( 36 % ) treatment-group patients achieved the secondary end point . LIMITATIONS Small sample size , not double blind . CONCLUSIONS A 27-month course of EDTA chelation therapy retards the progression of diabetic nephropathy in type 2 diabetic patients with high-normal body lead burdens .
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Intervention_Pharmacological
chelation therapy
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Intervention_Pharmacological
EDTA chelation therapy
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Participant_Condition
type 2 diabetes
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Participant_Condition
high-normal body lead burdens
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Participant_Condition
type 2 diabetic