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ADI-PEG20, Obesity and Prediabetes
Th purpose of this study is to determine whether ADI-PEG20 (PEGylated arginine deiminase), an arginine catabolizing enzyme preparation, improves insulin sensitivity, mitochondrial respiration, and energy utilization in adolescents with prediabetes.
Conditions:
🦠 Obesity 🦠 PreDiabetes
🗓️ Study Start (Actual) July 2024
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) May 2026
👥 Enrollment (Estimated) 48
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Saint Louis, Missouri, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * age: ≥18 and ≤22 years;
    • * BMI 25.0 - 44.9 kg/m2;
    • * Prediabetes, defined as fasting plasma glucose of ≥100 mg/dL, or HbA1C ≥5.7%, or HOMA-IR ≥2.5.

    Exclusion Criteria:

    • * HbA1C ≥6.5%;
    • * Intolerance or allergies to ingredients in ADI-PEG20 or placebo;
    • * Taking dietary supplements or medications known to affect our study outcomes;
    • * Evidence of significant organ system dysfunction or diseases,
    • * Metallic implants, which would preclude MRI
Ages Eligible for Study: 18 Years to 22 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 11 November 2022
  • First Submitted that Met QC Criteria 24 April 2023
  • First Posted 25 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 April 2024
  • Last Update Posted 25 April 2024
  • Last Verified April 2024
I'm interested ...!!