RecruitingNCT05319990

Pathogenesis of Kidney Disease in Type 1 Diabetes: a Modern Kidney Biopsy Cohort (The PANDA Study)

Sponsor

University of Colorado, Denver

Enrollment

100 participants

Start Date

Mar 9, 2022

Study Type

OBSERVATIONAL

Conditions

Type 1 Diabetes Diabetic Kidney Disease Diabetic Nephropathies Diabetes Complications Autoimmune Diabetes

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. 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study follows people with Type 1 diabetes to understand why and how the kidneys become damaged over time, using modern tools like genomics and proteomics to find new biomarkers and treatment targets. **You may be eligible if...** - You have Type 1 diabetes - You are 18 or older - You are willing to provide blood, urine, and possibly tissue samples over time **You may NOT be eligible if...** - You have another type of diabetes (Type 2 or secondary) - You are unable or unwilling to give consent - You have a condition that makes participating unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAminohippurate Sodium Inj 20% Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)

PAH (Basic Pharma, Geleen, Netherlands) has been used to measure ERPF in human research for 7 decades, and is very well tolerated and generally recognized as safe with low toxicity.

DRUGIohexol Inj 300 MG/ML Diagnostic aid/agent used to measure glomerular filtration rate (GFR)

Iohexol (Omnipaque 300, GE Healthcare, Chicago, IL) is a nonionic, low osmolar contrast agent with a history of extensive use in Radiology practice (for contrast x-rays) that shares many qualities of an ideal GFR marker, like inulin, such as not being absorbed, metabolized, or secreted by the kidney.