Status:
COMPLETED
Environmental Exposure to Lead and Progressive Renal Insufficiency in Type II Diabetic Nephropathy
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Diabetic Nephropathies
Diabetes Mellitus, Type II
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
Background The relationship between long-term heavy lead exposure and chronic interstitial nephropathy is well recognized in the previous literatures. Several epidemiological studies have demonstrated...
Eligibility Criteria
Inclusion
- Patients from 20 through 80 years of age who have type II diabetes mellitus with diabetic nephropathy and followed up at our hospital for more than one year were eligible if they have a serum creatinine concentration between 1.5 mg per deciliter (132.6 μmol per liter) and 3.9 mg per deciliter (344.8 μmol per liter), with a daily proteinuria more than 0.5g/day and no micro-hematuria in urinalysis tests, normal size of both kidneys, retinopathy with laser therapy by ophthalmologists, a history of diabetes more than 5 years and no known history of exposure to lead or other heavy metals (body lead burden, less than 600 μg \[2.90 μmol\], as measured by EDTA mobilization testing and 72-hour urine collection). Diabetic nephropathy diagnoses are based on the patients' history and the results of laboratory evaluations, renal imaging, and renal histological examination.
Exclusion
- type I diabetes; renal insufficiency with a potentially reversible cause, such as malignant hypertension, urinary tract infection, hypercalcemia, or drug-induced nephrotoxic effects; other systemic diseases, such as connective-tissue diseases; use of drugs that may alter the course of renal disease, such as non-steroidal anti-inflammatory agents, steroids, immunosuppressive drugs or Chinese herb drugs.; previous marked exposure to lead (lead poisoning or occupational exposure); drug allergies; and absence of informed consent.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00237952
Start Date
August 1 2005
Last Update
June 23 2009
Active Locations (2)
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1
Chang Gung Memorial Hospital, Lin-Kou Medical Center
Taipei, Taiwan, China, 105
2
Chang Gung Memorial Hospital
Taipei, Taiwan, China, 105