Status:
RECRUITING
Pathogenesis of Kidney Disease in Type 1 Diabetes: a Modern Kidney Biopsy Cohort (The PANDA Study)
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Diabetic Kidney Disease
Eligibility:
All Genders
18+ years
Brief Summary
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. Lan...
Detailed Description
The overall goal of this project is to characterize the molecular, morphometric, and metabolic features of DKD over the modern clinical course of T1D. The investigators hypothesize that perturbed kidn...
Eligibility Criteria
Inclusion
- Age ≥ 18 years at enrollment (rationale: this study focuses on determinants of early DKD over the course of T1D in adults)
- T1D duration \>5 years (rationale: DKD in T1D rarely manifests prior to 5 years of disease duration)
- HbA1c \<11% (rationale: HbA1c ≥ 11% exceeds the average HbA1c at most academic center and would limiting the generalizability of our study findings)
Exclusion
- T2D and monogenic diabetes (rationale: our study focuses on T1D)
- Recent diabetic ketoacidosis, i.e., \<1 month (rationale: safety and insulin resistance and tubular dysfunction of DKA can confound study findings)
- eGFR \< 30 ml/min/1.73m2 or dialysis treatment (rationale: to reduce the likelihood of identifying secondary pathways that are not specific to kidney injury from T1D)
- Kidney transplant recipients (rationale: molecular confounding from immunosuppression)
- Kidney biopsy contraindications (rationale: safety - kidney biopsy):
- Evidence of bleeding disorder or complications from bleeding
- Use of aspirin, Nonsteroidal anti-inflammatory drugs (NSAIDS) or other blood thinner that cannot be safely stopped for a sufficient time before and after the biopsy to avoid additional risk of bleeding.
- INR \> 1.4
- Hemoglobin (Hgb) \< 10 mg/dL (Colorado) \[altitude\]
- Hemoglobin (Hgb) \< 9 mg/dL (Washington)
- Platelet count \< 100,000 / µL
- Uncontrolled or difficult to control hypertension (\> 150/90 mmHg at the day of biopsy)
- Single kidney (either by history, documented by prior imaging or ultrasound performed prior to the biopsy)
- Kidney size: One or both kidneys \< 8 cm
- Hydronephrosis or other important renal ultrasound findings such as significant stone disease
- Any evidence of a current urinary tract infection as indicated on day of biopsy
- Clinical evidence of non-diabetic renal disease
- Positive urine pregnancy test or pregnancy
Key Trial Info
Start Date :
March 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05319990
Start Date
March 9 2022
End Date
December 31 2027
Last Update
April 10 2024
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045