Type 2 Diabetic Nephropathy With Elevated Blood Lead Burden
Conditions
Brief summary
This is a single-arm prospective clinical study conducted at The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Previous basic research has found that patients with type 2 diabetic nephropathy have higher blood lead levels than ordinary people, and lead accumulation may accelerate kidney function decline. A total of 42 eligible participants will be enrolled, who are diagnosed with type 2 diabetic nephropathy, have baseline blood lead ≥5 µg/dl, CKD stage ≤3 and 24-hour urinary protein \<8 g. All subjects will receive oral dimercaptosuccinic acid (DMSA) capsules for lead removal according to standardized treatment courses for up to 3 months. During treatment, blood lead, urine lead, renal function and other indicators will be tested monthly. After the 3-month intervention, all participants will be followed up for 12 months, with relevant laboratory examinations conducted every 3 months to observe changes in renal function. The main goal of this study is to evaluate whether oral lead chelation therapy can slow the progression of kidney damage in patients with high lead burden and type 2 diabetic nephropathy, and provide clinical evidence for the intervention of lead-induced kidney injury in diabetic populations. Patients with hypertension, hyperlipidemia, autoimmune diseases, malignant tumor history, previous occupational lead exposure or drug allergies will not be enrolled. No healthy volunteers will be recruited, and individual raw patient data will not be shared externally after the study.
Interventions
DRUGDimercaptosuccinic acid oral chelation therapy
Oral dimercaptosuccinic acid capsules with two optional oral dosing regimens for lead removal in lead-loaded type 2 diabetic nephropathy patients. The treatment lasts up to 3 months with regular monthly laboratory monitoring, followed by 12-month follow-up to observe renal function changes, differing from intravenous chelation intervention in other studies.
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; 6. Able to voluntarily sign a written informed consent form.
Exclusion criteria
1. Combined hypertension or hyperlipidemia; 2. Confirmed history of autoimmune diseases; 3. Personal history of malignant tumors; 4. Reversible renal insufficiency (malignant hypertension, active urinary tract infection, recent use of nephrotoxic drugs); 5. Previous occupational lead exposure history; 6. Known drug allergy to dimercaptosuccinic acid; 7. Unable to complete regular follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in estimated glomerular filtration rate (eGFR) from baseline at 12 months after oral chelation therapy | 3 months oral chelation intervention, followed by 12 months of quarterly follow-up assessment, with the primary endpoint measured at the 12-month post-treatment visit |
Contacts
CONTACTXin Li
Outcome results
None listed