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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 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.

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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.

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

FieldValue
Enrollment Target 88 participants
Start Date 2019-12-15
Est. Completion 2026-12
Phase Phase 4

What the Registry Record Tells You About NCT04128995

The ClinicalTrials.gov registry entry for NCT04128995 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (98% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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