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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Nationwide Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01231074
First received: September 13, 2010
Last updated: October 29, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Obesity
Weight Gain
Psychotropic Induced Weight Gain
Drug: Metformin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Antipsychotic-Induced Weight Gain in Children With Metformin

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Change in weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Weight trajectory based on length of intervention and factors that predict response to Metformin [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 96
Study Start Date: February 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Experimental: Obese/metformin (OME)
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.
Other Names:
  • glucophage
  • fortamet
  • glucophage xr
  • glumetza
  • riomet

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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231074

Contacts
Contact: Ihuoma Eneli, MD, MS 614-722-4089 ihuoma.eneli@nationwidechildrens.org
Contact: Mary Ann Murphy, MD, PhD 614-722-2291 maryann.murphy@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Ihuoma Eneli, MD, MS    614-722-4089    ihuoma.eneli@nationwidechildrens.org   
Contact: Mary Ann Murphy, MD, PhD    614-722-2291    maryann.murphy@nationwidechildrens.org   
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Ihuoma Eneli, MD Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Ihuoma Eneli,MD, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01231074     History of Changes
Other Study ID Numbers: IRB 0900237
Study First Received: September 13, 2010
Last Updated: October 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
obesity
weight gain
metformin
psychotropic drugs

Additional relevant MeSH terms:
Weight Gain
Body Weight
Body Weight Changes
Obesity
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms
Metformin
Psychotropic Drugs
Antipsychotic Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 16, 2014