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Surgical or Medical Treatment

Study acronym: ST2OMP
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Dec 2026v11
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 100 to confirmed 88 · Primary completion date: Sep 1, 2025 to Dec 2025 · Completion date: Dec 1, 2026 to Dec 2026 · 1 morev10 Show 4 more changesShow less
    • Enrollment target: estimated 100 to confirmed 88
    • Primary completion date: Sep 1, 2025 to Dec 2025
    • Completion date: Dec 1, 2026 to Dec 2026
    • Site details revised at 3 of 3 sites
  3. Primary completion date: Sep 1, 2024 to Sep 1, 2025 Completion date: Dec 1, 2025 to Dec 1, 2026v9 Show 1 more changeShow less
    • Completion date: Dec 1, 2025 to Dec 1, 2026
  4. Completion date: Sep 1, 2025 to Dec 1, 2025v8
  5. Eligibility criteria expanded, about 31 wordsv7 See this version in full on ClinicalTrials.gov ↗
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Jan 5, 2024 to Sep 1, 2024 Enrollment target: 90 to 100 · Completion date: Aug 30, 2024 to Sep 1, 2025 · Interventions: Advanced Medical Therapy (Drug), Bariatric Surgery (Procedure) to Advanced Medical Therapy (Drug), Advanced Medical Therapy and Bariatric Surgery (Procedure), Bariatric Surgery (Procedure) · 3 morev6 Show 6 more changesShow less
    • Enrollment target: 90 to 100
    • Completion date: Aug 30, 2024 to Sep 1, 2025
    • Interventions: Advanced Medical Therapy (Drug), Bariatric Surgery (Procedure) to Advanced Medical Therapy (Drug), Advanced Medical Therapy and Bariatric Surgery (Procedure), Bariatric Surgery (Procedure)
    • Eligibility criteria expanded, about 90 words
    • Site contacts updated at 1 of 3 sites
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 2 to 3 Eligibility criteria revisedv5 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jan 5, 2022 to Jan 5, 2024v4
  4. Site contacts updated at 2 of 2 sitesv3
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 30, 2019 to Dec 15, 2019 · Site details revised at 2 of 2 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Nov 30, 2019 to Dec 15, 2019
    • Site details revised at 2 of 2 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will test the hypothesis that metabolic bariatric surgery will be more effective at providing durable glycemic control and reduce co-morbidities than intensive medical therapy in youth with type 2 diabetes.
Trial Details
NCT Number NCT04128995
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: Children's Hospital Colorado
Conditions Diabetes Mellitus, Type 2, Pediatric Obesity, Bariatric Surgery Candidate
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov