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NCT01231074 · ClinicalTrials.gov registry record · Phase 1
Reducing Antipsychotic-Induced Weight Gain in Children With Metformin
A Phase 1 study of Obesity and Weight Gain, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT01231074: Completed Phase 1 study of Obesity and Weight Gain, sponsored by Nationwide Children's Hospital.
NCT01231074 is a Phase 1 study of Obesity and Weight Gain that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 96 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01231074, a Phase 1 study of Obesity and Weight Gain, has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study Summary
Recent but limited short term studies have shown that Metformin can slow down weight gain in obese children and in children with psychotropic-induced weight gain, two distinct pediatric populations that are at risk for obesity related co-morbid conditions. The purpose of this study is to conduct a long term prospective pilot cohort study to investigate the use of Metformin to prevent or decrease weight gain in two cohorts of children: 1) children with psychotropic induced weight gain on Metformin and 2) children with BMI above the 95th percentile on Metformin. Both study populations will be enrolled in a lifestyle weight management program
Primary Outcome
The change in weight(initial weight-final weight) at 4 weeks, 3 and 6 months. Each patient will have a weight trajectory, z-BMI calculated
Conditions Studied
Interventions
- DRUG Metformin
Study Locations (1)
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2010-02 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01231074 record still lists
NCT01231074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (88% lower).
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Metformin is the first listed.
NCT01231074 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01231074 about?
NCT01231074 is a clinical study titled "Reducing Antipsychotic-Induced Weight Gain in Children With Metformin". Recent but limited short term studies have shown that Metformin can slow down weight gain in obese children and in children with psychotropic-induced weight gain, two distinct pediatric populations that are at risk for obesity related co-morbid conditions. The purpose of this study is to conduct a l...
What is the current status of trial NCT01231074?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2010-02. Estimated completion is 2013-05.
What conditions does trial NCT01231074 study?
This clinical trial studies the following conditions: Obesity, Weight Gain, Psychotropic Induced Weight Gain.
What interventions are being tested in trial NCT01231074?
The interventions under investigation include: Metformin (DRUG).
Who is sponsoring clinical trial NCT01231074?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01231074 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
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 NCT01231074's enrollment target sits among peer trials
96 504th of 1053 higher than 545 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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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