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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05530356
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 26 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 30, 2022
Status verified
Oct 2022
Primary completion
Sep 30, 2027
Completion
May 31, 2029

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Lean Controls (previously enrolled in the Renal HEIR Study)
  • Arm: Obese Youth without Type 2 Diabetes (previously enrolled in the Renal HEIR Study)
  • Arm: Obese Youth with Type 2 Diabetes (previously enrolled in the Renal HEIR Study)

Primary Outcome Measure

Effective Renal Plasma Flow (ERPF) [ Time Frame: 4 Hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045-

Find similar trials in Aurora, CO

By condition
Obesity / overweightType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Children's Hospital Colorado· Aurora, CO

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