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

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

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

Sponsors & Collaborators

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Petter Bjornstad, MD · Children's Hospital Colorado

Eligibility

Min Age

12 Years

Max Age

26 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-30

Primary Completion

2027-09-30

Completion

2029-05-31

FDA Drug

Yes

Countries

• United States

Study Locations