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Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
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.
Conditions:
🦠 Type 2 Diabetes Mellitus 🦠 Diabetic Kidney Disease 🦠 Adolescent Obesity 🦠 Pre Diabetes 🦠 Kidney Hypoxia 🦠 Puberty
🗓️ Study Start (Actual) 27 September 2021
🗓️ Primary Completion (Estimated) 1 December 2027
✅ Study Completion (Estimated) 1 December 2027
👥 Enrollment (Estimated) 100
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Aurora, Colorado, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * HbA1c ≥6.0% for untreated high-risk group
    • * BMI ≥ 95th %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
Ages Eligible for Study: 8 Years to 14 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 August 2021
  • First Submitted that Met QC Criteria 9 August 2021
  • First Posted 17 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 April 2024
  • Last Update Posted 11 April 2024
  • Last Verified April 2024
I'm interested ...!!