Lead-Burdened Type 2 Diabetic Nephropathy
Conditions
Brief summary
Based on previous basic experiments revealing that patients with type 2 diabetic nephropathy exhibit higher blood lead levels than the general population, this study aims to systematically evaluate the impacts of short-term and long-term blood lead exposure on renal function progression in such patients, so as to provide novel epidemiological evidence for clinical intervention.
Interventions
DRUGchelator
Calcium Disodium Edetate Injection
Sponsors
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Diagnosed with type 2 diabetic nephropathy; 2. Baseline blood lead level ≥5 µg/dl; 3. Chronic kidney disease stage ≤3; 4. 24-hour urinary protein \< 8 g; 5. Age ≥18 years old; 6. Able to provide written informed consent.
Exclusion criteria
* 1\. Combined hypertension; 2. Combined hyperlipidemia; 3. History of autoimmune diseases; 4. Personal history of malignant tumors; 5. Reversible renal insufficiency (malignant hypertension, urinary tract infection, recent use of nephrotoxic drugs); 6. Past occupational lead exposure history; 7. Drug allergy to calcium disodium edetate; 8. Unable to complete follow-up or provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in estimated glomerular filtration rate (eGFR) from baseline at 12 months follow-up after intravenous lead chelation therapy | 3 months of intravenous lead chelation intervention, followed by 12 months of follow-up assessment with detections every 3 months |
Contacts
CONTACTXin Li
Outcome results
None listed