Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05008276

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age8 Years to 14 Years

SexAll

Healthy volunteersAccepted

ConditionType 2 Diabetes Mellitus, Diabetic Kidney Disease, Adolescent Obesity, Pre Diabetes, Kidney Hypoxia, Puberty

Full registry criteria

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

Treatments and study arms

Aminohippurate Sodium Inj 20%

Drug

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

Iohexol Inj 300 MG/ML

Drug

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

Dextran 40

Drug

Diagnostic aid/agent used to measure glomerular size and selectivity

Primary outcomes

Effective renal plasma flow (ERPF)3 Hours

Measured by PAH Clearance

Glomerular Filtration Rate (GFR)3 hours

Measured by iohexol clearance

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Children's Hospital Colorado🇺🇸 Aurora, Colorado, United States

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Megan Kelsey, MD, MSContact

Email · Call 720-777-0991

Megan Kelsey, MD, MSPrincipal Investigator

Seattle Children's Hospital🇺🇸 Seattle, Washington, United States

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Petter M Bjornstad, MDContact

Email · Call (206) 616 3543

Petter M Bjornstad, MDPrincipal Investigator