Understanding how puberty affects kidney health in youth with diabetes
PANTHER Study: Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress
This study looks at how puberty affects kidney health in teenagers with type 2 diabetes and obesity to see if the changes during this time can harm their kidneys.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 8 Years to 14 Years |
| Sex | All |
| Sponsor | Seattle Children's Hospital Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT05008276 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between puberty and kidney health in adolescents with type 2 diabetes and obesity. It aims to understand how the physiological changes during puberty may lead to kidney injury, particularly focusing on the concept of kidney hypoxia. The study will utilize functional magnetic resonance imaging (MRI) and other assessments over a five-year period to evaluate the impact of these changes on kidney function. By identifying the mechanisms linking puberty and diabetic kidney disease, the research seeks to inform strategies for preserving kidney health in affected youth.
Who should consider this trial
Good fit: Ideal candidates include adolescents with type 2 diabetes or prediabetes who are obese and have specific HbA1c levels.
Not a fit: Patients with a history of chronic kidney disease or acute kidney injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing kidney disease in adolescents with type 2 diabetes.
How similar studies have performed: While there is emerging data on the impact of puberty on kidney health, this specific approach to studying the relationship in youth with diabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado and 1 other locations
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Petter Bjornstad, MD — University of Washington - Medicine Diabetes Institute
- Study coordinator: Petter Bjornstad, MD
- Email: pettermb@uw.edu
- Phone: (206) 616 3543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.