Reducing Antipsychotic-Induced Weight Gain in Children With Metformin
Completed · Phase 1
Conditions studied: Obesity, Weight Gain, Psychotropic Induced Weight Gain
In brief
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
Key facts
- Study ID
- NCT01231074
- Run by
- Nationwide Children's Hospital
- People needed
- 96
- Starts
- 2010-02-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2019-01-02
Who can join
Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children aged 10-17
- Currently prescribed one of the following psychotropic medications: Haloperidol, perphenazine, clozapine, olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, thioridazine, chlorprothixene, loxapine, mesoridazine, thiothixene or trifluoperazine.
- Documented weight gain while on prescribed medications
- Either >5% weight increase from the start of medication through 3 months on, or crossing into the 95th percentile for BMI, or crossing into the 85-95th percentile plus one obesity related complication.
- Children aged 10-17 years old with BMI >95th percentile and fasting insulin level>21.7U/L not currently on psychotropic medications
You may not qualify if…
- History of liver disease
- History of kidney disease
- Abnormal creatinine
- Abnormal liver function blood levels -
Where it is running
- Nationwide Children's Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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