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

  • End date
    Sep 1, 2026
  • participants needed
  • sponsor
    University of Colorado, Denver
Updated on 25 March 2022
insulin resistance
glomerular filtration rate
hemoglobin a1c
Accepts healthy volunteers


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.

Puberty is a complex process of physiological changes, including neuroreproductive and growth hormone activation and rapid organ growth, that may predispose organs to injury. The kidneys may be especially susceptible because they are highly metabolically active and second only to the heart with respect to oxygen consumption per tissue mass. During puberty, the kidneys almost double in size, likely increasing the kidneys' already high energy expenditure. In parallel, puberty is associated with physiologic insulin resistance (IR), which is accentuated in obesity. Our central hypothesis is that obese youth with prediabetes and T2D experience relative kidney hypoxia during puberty due to a metabolic mismatch between increased energy expenditure and impaired substrate metabolism. In turn, the kidney hypoxia results in loss of glomerular charge and size selectivity leading to increased transglomerular transport of protein and kidney dysfunction. Our preliminary data showed that pubertal adolescents with obesity and/or diabetes exhibit relative kidney hypoxia compared to normal weight controls using functional magnetic resonance imaging (MRI) and that relative kidney hypoxia is greater in late vs. early puberty. However, determining the pubertal mechanisms contributing to kidney injury in youth with obesity and T2D requires serial evaluations throughout puberty. To assess the impact of pubertal changes within a 5-year study period, the investigators propose an accelerated longitudinal study design in which the investigators will enroll adolescents (8-14 years, 50% girls) with obesity and elevated hemoglobin A1c (HbA1c ≥6%) [n=60], and healthy normal weight controls [n=40] at Tanner (pubertal) stages 1-4 and examine them at baseline, 1 and 2-years. The investigators will then compare data by Tanner stage to construct an integrated portrayal of the physiological changes that occur throughout puberty. Given the rarity of T2D prior to pubertal onset, the investigators chose to enroll a high high-risk group: youth with obesity and HbA1c ≥6.0% to represent youth ranging from those at magnified risk of developing T2D to those recently diagnosed.

Condition Type 2 Diabetes Mellitus, Diabetic Kidney Disease, Adolescent Obesity, Pre Diabetes, Kidney Hypoxia, Puberty
Treatment Aminohippurate Sodium Inj 20%, Iohexol Inj 300 mg/mL, Dextran 40, Dextran 40
Clinical Study IdentifierNCT05008276
SponsorUniversity of Colorado, Denver
Last Modified on25 March 2022


Yes No Not Sure

Inclusion Criteria

HbA1c ≥6.0% for obese group
BMI ≥ 95th %ile for obese group
BMI ≥ 5 and <85th %ile 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
MRI contraindications
Hormone therapy
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