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NCT04128995 · ClinicalTrials.gov registry record · Phase 4
Surgical or Medical Treatment
A Phase 4 study of Diabetes Mellitus, Type 2 and Pediatric Obesity, sponsored by Children's Hospital Medical Center, Cincinnati.
- Active
- Registry status
- Phase 4
- Development phase
- 88
- Enrollment target
- 3
- Study locations
NCT04128995: Active Phase 4 study of Diabetes Mellitus, Type 2 and Pediatric Obesity, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04128995 is a Phase 4 study of Diabetes Mellitus, Type 2 and Pediatric Obesity that is active but no longer recruiting, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 88 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04128995, a Phase 4 study of Diabetes Mellitus, Type 2 and Pediatric Obesity, is active but no longer recruiting, sponsored by Children's Hospital Medical Center, Cincinnati.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 88 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
Hemoglobin A1c of \<6.5%
Conditions Studied
Interventions
- PROCEDURE Bariatric Surgery
- PROCEDURE Advanced Medical Therapy and Bariatric Surgery
- DRUG Advanced Medical Therapy
Study Locations (3)
Colorado
- Children's Hospital Colorado - Aurora
Illinois
- Lurie Children's Hospital - Chicago
Ohio
- Cincinnati Childrens - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2019-12-15 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
What the registry record for NCT04128995 still lists
NCT04128995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Bariatric Surgery is the first listed.
NCT04128995 reports a single indexed study location in Colorado, Illinois, Ohio.
Frequently Asked Questions
What is clinical trial NCT04128995 about?
NCT04128995 is a clinical study titled "Surgical or Medical Treatment". 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.
What is the current status of trial NCT04128995?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 88 participants. The study started on 2019-12-15. Estimated completion is 2026-12.
What conditions does trial NCT04128995 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Pediatric Obesity, Bariatric Surgery Candidate.
What interventions are being tested in trial NCT04128995?
The interventions under investigation include: Bariatric Surgery (PROCEDURE), Advanced Medical Therapy and Bariatric Surgery (PROCEDURE), Advanced Medical Therapy (DRUG).
Who is sponsoring clinical trial NCT04128995?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04128995 being conducted?
This trial has 3 study locations across Colorado, Illinois, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04128995's enrollment target sits among peer trials
88 213th of 348 higher than 136 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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