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NCT05530356 · ClinicalTrials.gov record · last posted 2026-08-24

Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study

Study acronym: HEIRitage
StatusCompleted
PhaseNot specified
Started2022-09-30
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The current protocol plans to enroll participants with youth-onset Type 2 Diabetes (T2D) as well as obese and lean controls from the Renal-HEIR - Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study (n=100) \[COMIRB #16-1752\] in a prospective investigation that seeks to 1) define the changes in kidney function by gold standard techniques and energetics by functional Magnetic Resonance Imaging (MRI) in adolescents with and without T2D as they transition to young adulthood; 2) quantify kidney oxidative metabolism by 11C-acetate Positron Emission Tomography (PET) in a subset of participants who are ≥18 years of age with youth-onset T2D and/or obesity; 3) determine peripheral arterial stiffness by SphygmoCor. Mechanistic insight will be provided by transcriptomic analyses of repeat biopsies 3-years after their initial biopsy for eligible participants with youth-onset T2D, as well as molecular analysis of tissue obtained from J-wire endovascular biopsies. This study will also leverage this well-characterized cohort of youths to define youth-onset T2D-related changes in brain morphology and function by structural MRI and resting-state functional MRI and through the assessment of cognitive function (fluid and crystallized intelligence) using the NIH Toolbox Cognitive Battery (NIHTB-CB), as an exploratory objective. All enrollees in Renal-HEIR have consented to be contacted for future research opportunities.

Protocol amendment history 5 changes detected by DataLookout

2026-08-25
notable
Trial status changed: Enrolling by Invitation → Completed
2026-08-25
critical
Primary endpoint(s) modified
Was11-C Acetate Tracer Uptake, Blood Volume Fraction, Effective Renal Plasma Flow (ERPF), Glomerular Basement Membrane Width, Glomerular Filtration Rate, Glomerular Size Selectivity, Interstitial Fibrosis, Mesangial Expansion, Renal Arteriosclerosis, Renal Oxidative Metabolism, Renal Oxygen Availability, Renal Perfusion, Spatial Metabolomics, Spatial Transcriptomics
NowC-11 Acetate Tracer Uptake, Effective Renal Plasma Flow (ERPF), Glomerular Filtration Rate, Renal Oxidative Metabolism, Renal Oxygen Availability, Renal Perfusion
2026-08-25
critical
Enrollment reduced: 100 → 57 participants
2026-08-25
minor
Primary completion moved earlier: 2027-09 → 2024-06-19
2026-08-25
minor
Completion moved earlier: 2029-05 → 2024-06-19
Trial Details
NCT Number NCT05530356
Lead Sponsor University of Colorado, Denver
Conditions Type 2 Diabetes, Diabetes Type 2, Diabetic Nephropathies, Nephropathy, Obesity, Adolescent Obesity, Diabetic Kidney Disease
Enrollment 57 participants
Start Date 2022-09-30
Primary Completion 2024-06-19 (estimated)
Study Completion 2024-06-19 (estimated)
Updated on ClinicalTrials.gov 2026-08-24