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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 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.

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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

Interventions

  • DRUG Metformin

Study Locations (1)

Ohio

  • Nationwide Children's Hospital - Columbus

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2010-02
Est. Completion 2013-05
Phase Phase 1

Sponsor

Nationwide Children's Hospital

188 total trials

What the Registry Record Tells You About NCT01231074

The ClinicalTrials.gov registry entry for NCT01231074 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (88% lower). The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.