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Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
This research study collects health-related information and blood samples to better understand how body composition, lifestyle habits, and diet influence meta-inflammatory monocytes (MiMos) in adolescents. The hypothesis of this study is that adolescents at risk for metabolic disease have enhanced MiMo related activities leading to insulin resistance.
Conditions:
🦠 Type 2 Diabetes 🦠 Insulin Resistance 🦠 Obesity 🦠 Metabolic Disease 🦠 PreDiabetes
🗓️ Study Start (Actual) 6 September 2023
🗓️ Primary Completion (Estimated) September 2027
✅ Study Completion (Estimated) September 2027
👥 Enrollment (Estimated) 175
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Ann Arbor, Michigan, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Between 14 and 18 years of age
    • * Tanner stage 4 or 5 (mature adult stage of puberty)
    • * Normal weight (BMI ≥ 5th percentile \& \< 85th percentile), obese weight (BMI percentile ≥ 95th percentile), and/or pre-diabetes (HbA1c \> 5.7%)
    • * For Type 2 Diabetes cohort, diagnosis of Type 2 Diabetes

    Exclusion Criteria:

    • * Currently pregnant
    • * Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids), unless prescribed for Type 2 Diabetes management
    • * Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability that would inhibit following directions of study staff
    • * Allergies or intolerance to milk, soy, or palm oil
Ages Eligible for Study: 14 Years to 18 Years (CHILD, ADULT)
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 10 June 2023
  • First Submitted that Met QC Criteria 17 August 2023
  • First Posted 23 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 31 May 2024
  • Last Update Posted 3 June 2024
  • Last Verified May 2024
I'm interested ...!!