RecruitingNCT05008276

Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)

PANTHER Study: Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress


Sponsor

Petter Bjornstad

Enrollment

100 participants

Start Date

Sep 27, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 14 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

Interventions

DRUGAminohippurate Sodium Inj 20%

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

DRUGIohexol Inj 300 MG/ML

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

DRUGDextran 40

Diagnostic aid/agent used to measure glomerular size and selectivity


Locations(2)

Children's Hospital Colorado

Aurora, Colorado, United States

Seattle Children's Hospital

Seattle, Washington, United States

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NCT05008276


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