NCT05319990
Pathogenesis of Kidney Disease in Type 1 Diabetes: a Modern Kidney Biopsy Cohort (The PANDA Study)
Active, Not Recruiting
Not specifiedAges 18+ObservationalUniversity of Colorado, DenverInvestigator-initiated
~100 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Aminohippurate Sodium Inj 20% Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)Iohexol Inj 300 MG/ML Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Renal Oxygenation
Measured over 30 min
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesColorado1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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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
What this trial measures
- Renal Oxygenation30 min
Blood oxygen level dependent (BOLD) MRI
- Renal Perfusion30 min
Arterial Spin Labeling (ASL) MRI
- Insulin Sensitivity4.5 hours
Hyperinsulinemic-Euglycemic Clamp