Background

A previous study in type 2 diabetic patients with high-normal body lead burdens showed that EDTA chelation for 3 months slows progressive diabetic nephropathy during a 12-month follow-up. The effect of a longer course of 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- Intervention

The results group received weekly chelation for 3 months to reduce their body lead burden to 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 .
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 results and control groups were similar. After 3 months of chelation , the change in eGFR in the results group (+1.0±4.8 mL/min/1.73 m2) differed significantly from that in the control group (−1.5±4.8 mL/min/1.73 m2; P = 0.04). In the subsequent 24-month intervention, the yearly rate of decrease in eGFR (5.6±5.0 mL/min/1.73 m2 per year) in the results group was slower than that (9.2±3.6 mL/min/1.73 m2 per year; P = 0.04) in the control group. 17 (68%) control-group patients and 9 (36%) results-group patients achieved the secondary end point.
Limitations

Small sample size, not double blind.
Conclusions

A 27-month course of EDTA chelation retards the progression of diabetic nephropathy in type 2 diabetic patients with high-normal body lead burdens.

URL: http://www.sciencedirect.com/science/article/pii/S0272638612008281