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Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
NCT05008276 · Seattle Children's Hospital
In plain English
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Official title
PANTHER Study: Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress
About this study
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/or elevated hemoglobin A1c (HbA1c ≥6%) \[n=60\], and healthy normoglycemic 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/or HbA1c ≥6.0% to represent youth ranging from those at magnified risk of developing T2D to those recently diagnosed.
Eligibility 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
Study design
Enrollment target: 100 participants
Age groups: child
Timeline
Starts: 2021-09-27
Estimated completion: 2027-12-01
Last updated: 2025-03-24
Interventions
Drug: Aminohippurate Sodium Inj 20%Drug: Iohexol Inj 300 MG/MLDrug: Dextran 40
Primary outcomes
- • Effective renal plasma flow (ERPF) (3 Hours)
- • Glomerular Filtration Rate (GFR) (3 hours)
Sponsor
Petter Bjornstad · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Seattle Children's Hospital, University of Colorado, Denver
Contacts & investigators
ContactPetter Bjornstad, MD · contact · pettermb@uw.edu · (206) 616 3543
InvestigatorPetter Bjornstad, MD · principal_investigator, University of Washington - Medicine Diabetes Institute
All locations (2)
Children's Hospital ColoradoRecruiting
Aurora, Colorado, United States
Seattle Children's HospitalRecruiting
Seattle, Washington, United States