RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-09

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05319990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Carissa Birznieks, MS

CONTACT

720-777-4659

Carissa.Birznieks@childrenscolorado.org

Petter M Bjornstad, MD

CONTACT

720-777-4659

petter.m.bjornstad@cuanschutz.edu

Study Locations (Sites)

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-09

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2022-03-09

Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

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