Actively Recruiting
PANTHER Study: Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress
Led by Petter Bjornstad · Updated on 2025-03-24
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Petter Bjornstad
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how puberty affects kidney health in youth with obesity, prediabetes, or type 2 diabetes (T2D), conditions that increase the risk of diabetic kidney disease (DKD). The study focuses on understanding how puberty-related changes, including rapid kidney growth and insulin resistance, may lead to kidney injury in these young individuals. This research aims to better understand the link between puberty and kidney disease to help preserve kidney function in youth with T2D. The study follows adolescents aged 8 to 14 years, including those with obesity and/or elevated hemoglobin A1c (HbA1c ≥6.0%) considered high-risk, and healthy normal-weight controls with normal HbA1c (≤5.6%). Participants will be evaluated at baseline, 1 year, and 2 years, with assessments of kidney function and metabolism. Procedures include measuring glomerular filtration rate (GFR) using Iohexol, effective renal plasma flow (ERPF) using Aminohippurate Sodium, and glomerular size and selectivity using Dextran 40. Kidney MRI techniques (BOLD and ASL) will assess kidney oxygenation and perfusion. Participants will undergo detailed kidney function tests and insulin sensitivity assessments during study visits lasting approximately 3 hours. These include blood tests, imaging scans, and diagnostic infusions to measure kidney blood flow and filtration. Researchers will monitor changes in kidney function and metabolism across puberty stages to understand how puberty impacts kidney health in youth with obesity and/or T2D. The study will continue until 2027, with safety and kidney health closely observed throughout the follow-up period.
CONDITIONS
Brief Title
Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HbA1c 6.0% or higher for untreated high-risk group
- Body mass index (BMI) at or above the 85th percentile for high-risk group
- Normal HbA1c 5.6% or lower for healthy control group
- Negative for type 1 diabetes antibodies
You will not qualify if you...
- History of chronic kidney disease or acute kidney injury
- Metabolic disorders that prevent safe fasting
- Allergy to iodine or penicillin
- Pregnancy
- Thrombophilia (blood clotting disorder)
- Contraindications for MRI scans
- Current hormone therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline, 1 year, and 2 years
Participants undergo diagnostic tests including measurement of kidney function and insulin sensitivity using injections and MRI scans.
3 visits (in-person) over 2 years
Duration - Up to 5 years
Participants are followed to monitor kidney function changes throughout puberty with repeated assessments.
Periodic visits coinciding with diagnostic evaluations
Trial Site Locations
Total: 2 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Seattle Children's Hospital
Seattle, Washington, United States, 98102
Actively Recruiting
Research Team
P
Petter Bjornstad, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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