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Reducing Antipsychotic-Induced Weight Gain in Children With Metformin (GFMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01231074
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : January 2, 2019
Sponsor:
Information provided by (Responsible Party):
Ihuoma Eneli, Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE September 13, 2010
First Posted Date  ICMJE November 1, 2010
Last Update Posted Date January 2, 2019
Study Start Date  ICMJE February 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2010)
Change in weight [ Time Frame: 6 months ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2010)
Weight trajectory based on length of intervention and factors that predict response to Metformin [ Time Frame: 6 months ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Antipsychotic-Induced Weight Gain in Children With Metformin
Official Title  ICMJE Reducing Antipsychotic-Induced Weight Gain in Children With Metformin
Brief 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
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Weight Gain
  • Psychotropic Induced Weight Gain
Intervention  ICMJE 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.
Other Names:
  • glucophage
  • fortamet
  • glucophage xr
  • glumetza
  • riomet
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Drug: Metformin
  • Experimental: Obese/metformin (OME)
    Obese/metformin (OME) cohort: Children 10-17 years old with BMI >95th percentile and fasting insulin level>21.7U/L
    Intervention: Drug: Metformin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2010)
96
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01231074
Other Study ID Numbers  ICMJE IRB 0900237
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ihuoma Eneli, Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ihuoma Eneli, MD Nationwide Children's Hospital
PRS Account Nationwide Children's Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP