Actively Recruiting
Pathogenesis of Kidney Disease in Type 1 Diabetes: a Modern Kidney Biopsy Cohort (The PANDA Study)
Led by University of Colorado, Denver · Updated on 2024-04-10
100
Participants Needed
1
Research Sites
303 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Diabetic kidney disease (DKD) occurs in up to 40% of people with type 1 diabetes (T1D), often leading to kidney failure and markedly magnifying risks of cardiovascular disease and premature death. Landmark T1D kidney biopsy studies identified the classic pathological lesions of DKD, which have been attributed largely to hyperglycemia. Recent advances in continuous glucose monitoring (CGM) and automated insulin delivery have facilitated improved glycemic control, but the residual risk of DKD continues to be high. In addition, obesity and insulin resistance (IR) have accompanied intensive glycemic therapy and may promote mitochondrial dysfunction and inflammation. Deciphering the molecular underpinnings of DKD in modern-day T1D and identifying modifiable risk factors could lead to more effective and targeted therapies to prevent DKD.
CONDITIONS
Official Title
Pathogenesis of Kidney Disease in Type 1 Diabetes: a Modern Kidney Biopsy Cohort (The PANDA Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 18 years at enrollment
- Type 1 diabetes duration greater than 5 years
- HbA1c less than 11%
You will not qualify if you...
- Type 2 diabetes or monogenic diabetes
- Diabetic ketoacidosis within the last month
- Estimated glomerular filtration rate less than 30 ml/min/1.73m2 or dialysis treatment
- Kidney transplant recipients
- Any contraindications to kidney biopsy including bleeding disorders, use of blood thinners that cannot be stopped safely, INR over 1.4, low hemoglobin (less than 10 mg/dL in Colorado or less than 9 mg/dL in Washington), platelet count under 100,000 / bcl, uncontrolled hypertension over 150/90 mmHg on biopsy day, single kidney, kidney size under 8 cm, renal ultrasound abnormalities such as hydronephrosis or significant stones, current urinary tract infection, clinical evidence of non-diabetic kidney disease, pregnancy or positive pregnancy test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
C
Carissa Birznieks, MS
CONTACT
P
Petter M Bjornstad, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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