Reducing Antipsychotic-Induced Weight Gain in Children With Metformin

NCT01231074 | Completed Phase 1

• 1 other identifier: IRB 0900237
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Weight Gain; Psychotropic Induced Weight Gain

Keywords

obesity; weight gain; metformin; psychotropic drugs

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (1)

• Weight trajectory based on length of intervention and factors that predict response to Metformin

  6 months

Study Arms (2)

Psychotropic/metformin (PIW)

EXPERIMENTAL

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)

EXPERIMENTAL

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

Drug: Metformin

Interventions

Metformin DRUG

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

Obese/metformin (OME); Psychotropic/metformin (PIW)

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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 -

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Obesity; Weight Gain

Interventions

Metformin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Ihuoma Eneli, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Healthy Weight and Nutrition; Professor of Pediatrics, The Ohio State University

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: November 1, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2013
• Last Updated: January 2, 2019

Record last verified: 2018-12

Locations

US (1)