NCT05530356

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

Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes: A Follow-up Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 12 Years – 26 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Type 2 Diabetes
• Diabetes Type 2
• Diabetic Nephropathies
• Nephropathy
• Obesity
• Adolescent Obesity
• Diabetic Kidney Disease

Interventions

Type	Name	Description
DRUG	Aminohippurate Sodium Inj 20%	Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)
DRUG	Iohexol Inj 300 MG/ML	Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
DRUG	Dextran 40	Diagnostic aid/agent used to measure glomerular size selectivity
PROCEDURE	Renal Biopsy	Minimally invasive outpatient procedure in interventional radiology to obtain renal tissue cores.
RADIATION	Positron Emission Tomography	Imaging study performed to study renal oxidative metabolism

Timeline

• Start date: 2022-09-30
• Primary completion: 2027-09-01
• Completion: 2029-05-01
• First posted: 2022-09-07
• Last updated: 2022-11-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study