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

NCT ID: NCT05530356

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2029-05-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lean Controls (previously enrolled in the Renal HEIR Study)

Aminohippurate Sodium Inj 20%

Intervention Type: DRUG

Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)

Iohexol Inj 300 MG/ML

Intervention Type: DRUG

Diagnostic aid/agent used to measure glomerular filtration rate (GFR)

Dextran 40

Intervention Type: DRUG

Diagnostic aid/agent used to measure glomerular size selectivity

Obese Youth without Type 2 Diabetes (previously enrolled in the Renal HEIR Study)

Aminohippurate Sodium Inj 20%

Intervention Type: DRUG

Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)

Iohexol Inj 300 MG/ML

Intervention Type: DRUG

Diagnostic aid/agent used to measure glomerular filtration rate (GFR)

Dextran 40

Intervention Type: DRUG

Diagnostic aid/agent used to measure glomerular size selectivity

Positron Emission Tomography

Intervention Type: RADIATION

Imaging study performed to study renal oxidative metabolism

Obese Youth with Type 2 Diabetes (previously enrolled in the Renal HEIR Study)

Aminohippurate Sodium Inj 20%

Intervention Type: DRUG

Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)

Iohexol Inj 300 MG/ML

Intervention Type: DRUG

Diagnostic aid/agent used to measure glomerular filtration rate (GFR)

Dextran 40

Intervention Type: DRUG

Diagnostic aid/agent used to measure glomerular size selectivity

Renal Biopsy

Intervention Type: PROCEDURE

Minimally invasive outpatient procedure in interventional radiology to obtain renal tissue cores.

Positron Emission Tomography

Intervention Type: RADIATION

Imaging study performed to study renal oxidative metabolism

Interventions

Aminohippurate Sodium Inj 20%

Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)

Intervention Type: DRUG

Iohexol Inj 300 MG/ML

Diagnostic aid/agent used to measure glomerular filtration rate (GFR)

Intervention Type: DRUG

Dextran 40

Diagnostic aid/agent used to measure glomerular size selectivity

Intervention Type: DRUG

Renal Biopsy

Minimally invasive outpatient procedure in interventional radiology to obtain renal tissue cores.

Intervention Type: PROCEDURE

Positron Emission Tomography

Imaging study performed to study renal oxidative metabolism

Intervention Type: RADIATION

Other Intervention Names

Sodium 4-amino hippurate (PAH) inj 20% 2g/10mL; Para-aminohippurate; Aminohippuric acid; omnipaque 300; Dextran; LMD; Kidney Biopsy; PET Scan

Eligibility Criteria

Inclusion Criteria

• Obese youth with and without Type 2 Diabetes + lean controls who were previously enrolled in the Renal HEIR Study
• Participants who will undergo a PET Scan: ≥ 18 years

Exclusion Criteria

• Anemia
• Seafood, iodine, or penicillin allergy
• Pregnancy
• MRI Scanning contraindications (claustrophobia, implantable devices, >550 lbs)
• History of bleeding or clotting disorders, thrombocytopenia, warfarin and/or heparin use
• Taking sulfonamides, procaine, thiazolsulfone or probenecid

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petter Bjornstad, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

20-2961

Identifier Type: -

Identifier Source: org_study_id