New study probes why kidney disease still strikes in type 1 diabetes
NCT ID NCT05319990
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at why up to 40% of people with type 1 diabetes develop kidney disease, even with better blood sugar control. Researchers will use kidney biopsies and advanced imaging in 100 adults to find hidden risk factors like insulin resistance and inflammation. The goal is to uncover new ways to prevent or treat diabetic kidney disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could reveal new targets for preventing or treating diabetic kidney disease in type 1 diabetes.
- What could go wrong
- This is an observational study, not a treatment trial. It may not directly lead to new therapies, and findings may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The investigators propose to address the specific aims of this study in a cross-sectional project with 70 newly enrolled adults with T1D and 30 former CROCODILE participants (COMIRB #19-1282).
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital Colorado
Aurora, Colorado, 80045, United States
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Other studies related to the condition(s) this trial covers.
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