Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs
- Conditions
- Bipolar Disorder
- Interventions
- Behavioral: healthy lifestyle intervention (LIFE)
- Registration Number
- NCT02515773
- Lead Sponsor
- Melissa Delbello
- Brief Summary
A prospective, large, pragmatic, randomized trial to study the impact of METFORMIN and healthy lifestyle intervention (LIFE) vs. LIFE alone on patient-centered outcomes of body weight, SGA-adherence and satisfaction, psychiatric symptom burden (e.g. mood/anxiety), and Quality of Life.
- Detailed Description
The investigators propose to recruit 1800 overweight/obese youth with Bipolar Spectrum Disorder (BSD) who are prescribed second generation anti psychotics (SGAs) from at least 24 public and private mental health practices in the Greater Cincinnati and New York City regions, (approximately 900 each from \~12 Cincinnati region and \~12 Long Island/New York mental health treatment sites) to participate in the proposed patient-centered large pragmatic trial examining the effectiveness of MET and LIFE vs. LIFE alone. Patients will be eligible if they are ages 8-17 years old, inclusive, overweight or obese (BMI \> 85%), continuing or starting treatment with at least one SGA (i.e., olanzapine, clozapine, risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone, lurasidone, paliperidone, or asenapine) and have a clinical diagnosis of BSD (bipolar I or II disorder, cyclothymia, or bipolar or mood disorder not otherwise specified \[or by Diagnostic and Statistical Manual of Mental Disorders V (DSM-5), other specified bipolar or mood disorder). The enrollment rate will be 2-3 patients/month/site for a recruitment time of 30 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1565
Not provided
- Patients will be excluded if they have had exposure to a total daily dose of MET 1000 mg bid for at least 2 weeks in the past 3 months;
- Patients will be excluded if they could not tolerate MET during the recommended titration schedule outlined in the protocol;
- Major neurological or medical illnesses that affect weight gain (e.g., unstable thyroid disease) or require a systemic medication that might impact weight or glucose regulation (e.g., diabetes mellitus [insulin], chronic renal failure [steroids]);
- Fasting glucose ≥ 126 mg/dL on 2 occasions during screening indicating need for prompt treatment;
- If lab results are available in the last 6 months, then a serum creatinine ≥1.3 mg/dL on 2 occasions during screening and/or follow-up, indicating potential impairment of renal functioning;
- Pregnant or breast feeding;
- Children and caregivers who are unable to complete assessments for any reason;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MET and LIFE healthy lifestyle intervention (LIFE) Participants randomized to this group will receive both Metformin and lifestyle intervention.Participants randomized to treatment with MET will start at a dose of 500 mg orally at night and slowly titrated in 2-week intervals to ensure that each patient achieves maximum insulin-sensitizing effects of the drug while minimizing the chance of side effects. Investigators will also recommend that MET be taken with food to minimize side effects. If a participant's BMI percentile \<5% (=underweight) his/her treatment with MET will be discontinued. Although the risk of low vitamin B12 while taking MET is associated with age \> 50 years and having type II diabetes, Investigator will monitor B12 levels and a CBC throughout study participation. Healthy lifestyle intervention (LIFE) healthy lifestyle intervention (LIFE) Participants randomized to this group will receive just lifestyle intervention alone.This healthy lifestyle intervention (LIFE) consists of counseling participants and families regarding a healthy eating plan, physical activity and sedentary activities. Prior to study initiation, clinical site staff will participate in a live (or taped) training session from a dietician to lean to administer LIFE. A trained site staff member (e.g. medical assistant or case manager) will meet with participants and their families for a 15-20 minute session at baseline that will focus on nutritional issues using the Traffic Light Plan (TLP). MET and LIFE Metformin Participants randomized to this group will receive both Metformin and lifestyle intervention.Participants randomized to treatment with MET will start at a dose of 500 mg orally at night and slowly titrated in 2-week intervals to ensure that each patient achieves maximum insulin-sensitizing effects of the drug while minimizing the chance of side effects. Investigators will also recommend that MET be taken with food to minimize side effects. If a participant's BMI percentile \<5% (=underweight) his/her treatment with MET will be discontinued. Although the risk of low vitamin B12 while taking MET is associated with age \> 50 years and having type II diabetes, Investigator will monitor B12 levels and a CBC throughout study participation.
- Primary Outcome Measures
Name Time Method Change in BMI Z-score From Baseline to Month 6 in ITT Sample Baseline to Month 6 Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Change in BMI Z-score From Baseline to Month 24 in ITT Sample Baseline to Month 24 Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Change in BMI Z-score From Baseline to Month 6 in Per Protocol Sample Baseline to Month 6 Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
Change in BMI Z-score From Baseline to Month 24 in Per Protocol Sample Baseline to Month 24 Raw body mass index (BMI) is calculated as (weight(kg)/ height(m)2). This raw BMI value is converted to a normalized BMI z-score, adjusted for age and sex using US Centers for Disease Control and Prevention growth charts. A z-score equal to 0 indicates the population mean and larger z-scores are heavier weights and worse outcomes.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Ohio State University
🇺🇸Columbus, Ohio, United States
Children's Home
🇺🇸Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
St. Aloysius
🇺🇸Cincinnati, Ohio, United States
University Hospital Medical Center Cleveland
🇺🇸Cleveland, Ohio, United States
Maimonides
🇺🇸Brooklyn, New York, United States
South Oaks
🇺🇸Amityville, New York, United States
Jersey Shore Medical Center
🇺🇸Neptune, New Jersey, United States
The Children's Home of Northern Kentucky
🇺🇸Covington, Kentucky, United States
SUNY Downstate/ Kings County Hospital
🇺🇸Brooklyn, New York, United States
Northwell Zucker Long Island Jewish Hospital
🇺🇸Glen Oaks, New York, United States
Mount Sinai
🇺🇸New York, New York, United States
NYCCC
🇺🇸Brooklyn, New York, United States
LIJ Zucker Hillside Hospital
🇺🇸New York, New York, United States
NorthShore Child and Family Guidance
🇺🇸Roslyn Heights, New York, United States
Lighthouse Youth Services
🇺🇸Cincinnati, Ohio, United States
Child Center of New York,
🇺🇸Queens, New York, United States
Central Clinic
🇺🇸Cincinnati, Ohio, United States
StonyBrook
🇺🇸Stony Brook, New York, United States
Talbert House
🇺🇸Cincinnati, Ohio, United States
Resident Mood Medication Clinic
🇺🇸Cincinnati, Ohio, United States
St. Joseph's Orphanage
🇺🇸Cincinnati, Ohio, United States
Child Focus
🇺🇸Cincinnati, Ohio, United States
NECCO
🇺🇸Cincinnati, Ohio, United States
Nationwide Children's Hospital Columbus
🇺🇸Columbus, Ohio, United States
TCN Family Solutions
🇺🇸Xenia, Ohio, United States
South Community
🇺🇸Dayton, Ohio, United States
Butler Behavioral Health Services
🇺🇸Hamilton, Ohio, United States
Seton Family of Hospitals
🇺🇸Austin, Texas, United States