Understanding kidney disease in type 1 diabetes through modern biopsies
Pathogenesis of Kidney Disease in Type 1 Diabetes: a Modern Kidney Biopsy Cohort (The PANDA Study)
This study is trying to understand how kidney problems develop in people with type 1 diabetes by looking closely at kidney samples and using advanced technology to find new ways to prevent these issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05319990 on ClinicalTrials.gov |
What this trial studies
This project aims to characterize the molecular, morphometric, and metabolic features of diabetic kidney disease (DKD) in individuals with type 1 diabetes (T1D). By building a longitudinal kidney biopsy cohort of 100 participants, the study will investigate the role of kidney energetics and hypoxia in the development of DKD. The researchers will utilize advanced techniques such as single-cell RNA sequencing and MRI to explore the relationship between insulin resistance, mitochondrial dysfunction, and kidney health. The findings could lead to targeted therapies for preventing DKD in T1D patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with type 1 diabetes for more than 5 years and an HbA1c level below 11%.
Not a fit: Patients with type 2 diabetes, recent diabetic ketoacidosis, or severe kidney impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and targeted therapies to prevent diabetic kidney disease in patients with type 1 diabetes.
How similar studies have performed: While this study builds on previous findings, it employs novel methodologies and focuses on modern clinical factors, making it a unique approach in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Carissa Birznieks, MS
- Email: Carissa.Birznieks@childrenscolorado.org
- Phone: 720-777-4659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.