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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05530356
Other study ID # 20-2961
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 30, 2022
Est. completion date May 2029

Study information

Verified date October 2022
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date May 2029
Est. primary completion date September 2027
Accepts healthy volunteers
Gender All
Age group 12 Years to 26 Years
Eligibility 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

Study Design


Intervention

Drug:
Aminohippurate Sodium Inj 20%
Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)
Iohexol Inj 300 MG/ML
Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
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

Locations

Country Name City State
United States Children's Hospital Colorado Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effective Renal Plasma Flow (ERPF) Measured by PAH clearance 4 Hours
Primary Glomerular Filtration Rate Measured by Iohexol Clearance 4 Hours
Primary Glomerular Size Selectivity Measured by Dextran sieving 4 hours
Primary Renal Oxygen Availability Measured by functional kidney MRI 1 hour
Primary Renal Perfusion Measured by functional kidney MRI + PET Scan 1 hour
Primary 11-C Acetate Tracer Uptake Measured by PET Scan 1 Hour
Primary Renal Oxidative Metabolism Measured by PET Scan 1 Hour
Primary Blood Volume Fraction Measured by PET Scan 1 Hour
Primary Glomerular Basement Membrane Width Measured by Renal Biopsy 1 Hour
Primary Mesangial Expansion Measured by Renal Biopsy 1 Hour
Primary Interstitial Fibrosis Measured by Renal Biopsy 1 Hour
Primary Renal Arteriosclerosis Measured by Renal Biopsy 1 Hour
Primary Spatial Transcriptomics Measured by Renal Biopsy 1 Hour
Primary Spatial Metabolomics Measured by Renal Biopsy 1 Hour
Secondary Pulse Wave Velocity between Carotid and Femoral Artery Measured by PWV 10 minutes
Secondary Whole brain gray matter volume Measured by brain MRI 1 Hour
Secondary Whole brain cortical thickness Measured by brain MRI 1 Hour
Secondary Whole brain resting-state network connectivity Measured by brain MRI 1 Hour
Secondary Age-corrected composite fluid cognition score Measured by brain MRI 1 Hour
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