NCT05530356Completed
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
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 57 (actual)
- First submitted
- 2 Sept 2022
- Start date
- 30 Sept 2022
- Primary completion date
- 19 Jun 2024
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Chronic kidney disease, Obesity, Type 2 diabetes
- NCT number
- NCT05530356
What you commit to
- Study type: Observational
- Participants enrolled: 57
- From 30 Sept 2022 to the primary completion date, 19 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Seafood, iodine, or penicillin allergy
- History of bleeding or clotting disorders, thrombocytopenia, warfarin and/or heparin use
Other
- Anemia
- Pregnancy
- MRI Scanning contraindications (claustrophobia, implantable devices, \>550 lbs)
- Taking sulfonamides, procaine, thiazolsulfone or probenecid
Who the study is looking for
- 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
Age in the registry: 12 years to 26 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.