Recruiting

Observational Study

Sponsor:

Petter Bjornstad

Code:

NCT05008276

Conditions

Type 2 Diabetes Mellitus

Diabetic Kidney Disease

Adolescent Obesity

Pre Diabetes

Kidney Hypoxia

Eligibility Criteria

Sex: All

Age: 8 - 14

Healthy Volunteers: Accepted

Interventions

Aminohippurate Sodium Inj 20%

Iohexol Inj 300 MG/ML

Dextran 40

Study Details

Brief summary:

Early diabetic kidney disease (DKD) occurs in 50-70% of youth with type 2 diabetes (T2D) and confers high lifetime risk of dialysis and premature death. Youth-onset T2D typically manifests during or shortly after puberty in adolescents with obesity. Epidemiological data implicate puberty as an accelerator of kidney disease in youth with obesity and diabetes and the investigators posit that the link between puberty and T2D-onset may explain the high burden of DKD in youth-onset T2D. A better understanding of the impact of puberty on kidney health is needed to promote preservation of native kidney function, especially in youth with T2D.

Conditions

Type 2 Diabetes Mellitus

Diabetic Kidney Disease

Adolescent Obesity

Pre Diabetes

Kidney Hypoxia

Study ID

NCT05008276

Start date

Sep 27, 2021

Status verified date

Mar, 2025

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 14

Healthy Volunteers: Accepted

Inclusion Criteria:

  • HbA1c ≥6.0% for untreated high-risk group
  • BMI ≥ 85th %ile for high-risk group
  • Normal HbA1c ≤5.6% for control group
  • Type 1 diabetes (T1D) Antibody negative

Exclusion Criteria:

  • History of Chronic kidney disease (CKD) or acute kidney injury (AKI)
  • Metabolic disorder prohibiting safe fasting
  • Iodine or penicillin allergy
  • Pregnancy
  • Thrombophilia
  • MRI contraindications
  • Hormone therapy

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Youth with overweight/obesity and/or newly diagnosed T2D and elevated HbA1c

All participants will undergo GFR (Iohexol Inj 300 MG/ML), EPRF (Aminohippurate Sodium Inj 20%), Dextran sieving (Dextran 40 Sodium Inj 0.9%), IVGTT for insulin sensitivity, in addition to BOLD and ASL Kidney MRI

Healthy normal-weight controls

All participants will undergo GFR (Iohexol Inj 300 MG/ML), EPRF (Aminohippurate Sodium Inj 20%), Dextran sieving (Dextran 40 Sodium Inj 0.9%), IVGTT for insulin sensitivity, in addition to BOLD and ASL Kidney MRI

Interventions

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 and selectivity

Primary outcome measure

  • Effective renal plasma flow (ERPF) [ Time Frame: 3 Hours ]
  • Glomerular Filtration Rate (GFR) [ Time Frame: 3 hours ]

Central Contacts and Locations

Central contacts

Petter Bjornstad, MD

(206) 616 3543pettermb@uw.edu

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Megan Kelsey, MD, MS

720-777-0991Megan.Kelsey@childrenscolorado.org

Principal Investigator:

Megan Kelsey, MD, MS

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98102

Contacts

Petter M Bjornstad, MD

(206) 616 3543pettermb@uw.edu

Principal Investigator:

Petter M Bjornstad, MD

More Information

Sponsor

Petter Bjornstad

Last update posted

Mar 24, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Petter Bjornstad on 2025-03-24.