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Obesity | Reducing Antipsychotic-Induced Weight Gain in Children With Metformin

Obesity research study

What is the primary objective of this study?

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

Who is eligible to participate?

Inclusion Criteria: 1. Children aged 10-17 2. Currently prescribed one of the following psychotropic medications: Haloperidol, perphenazine, clozapine, olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, thioridazine, chlorprothixene, loxapine, mesoridazine, thiothixene or trifluoperazine. 3. Documented weight gain while on prescribed medications 4. 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. 5. Children aged 10-17 years old with BMI >95th percentile and fasting insulin level>21.7U/L not currently on psychotropic medications Exclusion Criteria: 1. History of liver disease 2. History of kidney disease 3. Abnormal creatinine 4. Abnormal liver function blood levels -

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Obesity

Weight Gain

Psychotropic Induced Weight Gain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MetforminMetformin dosing will be done as is typical in clinical practice. Doses will be titrated at 500mg daily for one week, to a maximum dose of 1000mg twice a day as tolerated by subject.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Psychotropic/metformin (PIW)Inclusion Criteria:Psychotropic/metformin (PIW) Cohort: Children aged 10-17 years on psychotropic* medication with reported weight gain defined by 1 of the following: 1. >5% weight increase from the start of medication to 3 months on medication 2. Crossing into the 95th percentile for BMI 3. Crossing into the 85-95th percentile plus one obesity related complication The subject will have to be on one of these medications in addition to the criteria above to be eligible for the study: haloperidol, perphenazine, clozapine, olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, thioridazine, fluphenazine, loxapine, mesoridazine, thiothixene or trifluoperazine

Obese/metformin (OME)Obese/metformin (OME) cohort: Children 10-17 years old with BMI >95th percentile and fasting insulin level>21.7U/L

Study Status

Unknown status

Start Date: February 2010

Completed Date: May 2011

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Change in weight

Secondary Outcome: Weight trajectory based on length of intervention and factors that predict response to Metformin

Study sponsors, principal investigator, and references

Principal Investigator: Ihuoma Eneli, MD

Lead Sponsor: Nationwide Children's Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01231074

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