A Phase 1 interventional study of Metformin in Obesity, Weight Gain and Psychotropic Induced Weight Gain, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-01-02.
Sponsored by Nationwide Children's Hospital · Phase 1, Interventional, and Treatment
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
Approximately 21 percent of children, 12-17 years old are diagnosed with DSM IV disorders, with 11 percent exhibiting severe impairment and 5 percent severe emotional difficulties. By 18 years, 1-5 percent of children are diagnosed with bipolar disorder and up to 20 percent of children with depression. As greater numbers of children and adolescents have been diagnosed with these disorders in the last 10 years, the use of psychotropic drugs in the pediatric populations has increased. Many of the drugs prescribed are the newer antipsychotic drugs olanzapine, risperidone, and quetiapine, referred to as atypical antipsychotics. Compared to the older drugs, such as haldol and thorazine, atypical antipsychotics boast an improved safety profile, with fewer side effects such as tardive dyskinesia, extrapyramidal symptoms and hyperprolactinemia. This advantage has led to providers prescribing antipsychotic more frequently not only for psychotic conditions, but also for other behavioral problems, eg., oppositional defiant disorder, mood disorders, and autism spectrum disorders. In many ways, these medicines are life saving. They protect children from the fate of psychosis, unchecked rage and agitation, allowing the them a chance to grow up more normally.
Our study will provide preliminary evidence for the feasibility of using metformin as an adjunct for weight management in two vulnerable pediatric populations. We will apply for external funding for a large scale randomized clinical trial that will test efficacy of metformin in both our study populations with appropriate comparison groups. In addition, results from our exploratory analysis of patient characteristics eg., insulin level, eating behaviors) that may affect response to treatment will provide a basis to generate further hypothesis for mechanism of action.
Primary objective: Describe and compare the pattern of changes in weight trajectory in the (PIW) and (OME) group.
Secondary Objective: To conduct a preliminary investigation of factors(Baseline BMI, adherence, presence of gastrointestinal side effects, HOMA-IR, eating patterns) that influence the response to metformin.
1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.
This study's enrollment of 96 is above the median of 64 across 947 interventional studies indexed under Body Weight.
Browse Body Weight studies →Nationwide Children's Hospital is the lead sponsor of 231 studies on the registry; 43 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Metformin
Obese/metformin (OME) cohort: Children 10-17 years old with BMI \>95th percentile and fasting insulin level\>21.7U/L
Drug: Metformin
Metformin 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.
Also known as: glucophage, fortamet, glucophage xr, glumetza, riomet
Change in weight
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
Time frame: 6 months
Weight trajectory based on length of intervention and factors that predict response to Metformin
Weight trajectory based on length of intervention, ie. pattern of weight changes noted over 4 weeks, 3 and 6 months and factors that predict response to Metformin (baseline weight, body mass index, insulin level, HOMA-IR, insulin resistance calculated using fasting glucose to insulin ration
Time frame: 6 months
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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