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MOBILITY: Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs

Sponsor
Melissa Delbello (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02515773
Collaborator
Patient-Centered Outcomes Research Institute (Other)
1,800
Enrollment
29
Locations
2
Arms
84
Duration (Months)
62.1
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
MOBILITY- Metformin for Overweight & OBese ChILdren and Adolescents With BIpolar Spectrum Disorders Treated With Second-Generation AntipsYchotics
Study Start Date :
Dec 1, 2015
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: MET and 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.

Drug: Metformin
Metformin - to achieves maximum insulin-sensitizing effects
Other Names:
  • GLUCOPHAGE

    • Behavioral: healthy lifestyle intervention (LIFE)
    Healthy Life style intervention
    Other Names:
  • LIFE

    		•
    Experimental: 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).

    Behavioral: healthy lifestyle intervention (LIFE)
    Healthy Life style intervention
    Other Names:
  • LIFE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. BMI z-score [Screen/Baseline to Visit 24]

      BMI z-score will be computed from measurement of height and weight. Raw BMI is calculated as (weight(kg)/ height(m)2). Normalized BMI (z-score, adjusted for age and sex), will be calculated using the program provided by the USDA/ARS Children's Nutrition Research Center at Baylor College of Medicine (http://www.bcm.edu/cnrc/bodycomp/bmiz2.html). At each site weight will be measured with a Seca scale, model 882, calibrated to the nearest 0.2 kg per manufacturer instructions at intervals not to exceed 2 months using standard weights.

    Secondary Outcome Measures

    1. Composite Metabolic Health and Nutrition Measure [Screen/Baseline to Visit 24]

      As per clinical standards, blood pressure will be measured after 5 minutes of sitting at each patient visit. A minimum of 8-hour fasting total cholesterol, low-density lipoprotein (LDL)-cholesterol, high density lipoprotein (HDL)-cholesterol, triglycerides, glucose, insulin, and glycosylated hemoglobin (HbA1c) will be collected. For HTE analyses the homeostatic model assessment for insulin-resistance (HOMA-IR) will be computed as: (Insulin [IU/mL] x Glucose [mg/dL] /405). Following the modified ATPIII guidelines,130-132 metabolic syndrome is defined when >3 of the following: 1) abdominal obesity (BMI >90%ile, as in NHANES study of metabolic syndrome in youth133; 2) blood pressure >90%ile for height, age, sex; 3) fasting triglycerides >150 mg/dL; 4) low HDL cholesterol (males <40 mg/dL and for females <50 mg/dL); 5) fasting glucose >100 mg/dL Fulfillment of individual criteria and metabolic syndrome will be outcome measures.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    1. Inpatient or outpatient age 8-19 years inclusive; participants must live with a parent, guardian, or caregiver;

    2. Fluent in English;

    3. Diagnosed or told by a clinician that they have any of the following bipolar spectrum disorders (BSD): bipolar I, bipolar II, unspecified bipolar and related disorders, Disruptive Mood Dysregulation Disorder (DMDD), cyclothymic disorder, other specified bipolar and related disorders, as well as mood disorder not otherwise specified (if diagnosed in the past as per DSM-IV);

    4. Body mass index >85%ile for age and sex by standard growth charts;

    5. Received a new or ongoing prescription for at least one SGA (i.e., olanzapine, clozapine, risperidone, quetiapine, aripiprazole, ziprasidone, iloperidone, lurasidone, paliperidone, brexpiprazole or cariprazine) that is not prescribed as a PRN medication;

    Exclusion Criteria:

    1. 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;

    2. Patients will be excluded if they could not tolerate MET during the recommended titration schedule outlined in the protocol;

    3. 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]);

    4. Fasting glucose ≥ 126 mg/dL on 2 occasions during screening indicating need for prompt treatment;

    5. 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;

    6. Pregnant or breast feeding;

    7. Children and caregivers who are unable to complete assessments for any reason;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Children's Home of Northern Kentucky Covington Kentucky United States 41011
    2 Jersey Shore Medical Center Neptune New Jersey United States 07753
    3 South Oaks Amityville New York United States 11701
    4 SUNY Downstate/ Kings County Hospital Brooklyn New York United States 11203
    5 Maimonides Brooklyn New York United States 11219
    6 NYCCC Brooklyn New York United States 11233
    7 Northwell Zucker Long Island Jewish Hospital Glen Oaks New York United States 11004
    8 Mount Sinai New York New York United States 10029
    9 LIJ Zucker Hillside Hospital New York New York United States 11004
    10 Child Center of New York, Queens New York United States 11373
    11 NorthShore Child and Family Guidance Roslyn Heights New York United States 11577
    12 StonyBrook Stony Brook New York United States 11794
    13 Lighthouse Youth Services Cincinnati Ohio United States 45206
    14 Central Clinic Cincinnati Ohio United States 45219
    15 Children's Home Cincinnati Ohio United States 45227
    16 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    17 Resident Mood Medication Clinic Cincinnati Ohio United States 45229
    18 St. Aloysius Cincinnati Ohio United States 45237
    19 Talbert House Cincinnati Ohio United States 45238
    20 St. Joseph's Orphanage Cincinnati Ohio United States 45239
    21 Child Focus Cincinnati Ohio United States 45244
    22 NECCO Cincinnati Ohio United States 45246
    23 University Hospital Medical Center Cleveland Cleveland Ohio United States 44106
    24 Nationwide Children's Hospital Columbus Columbus Ohio United States 43205
    25 Ohio State University Columbus Ohio United States 43210
    26 South Community Dayton Ohio United States
    27 Butler Behavioral Health Services Hamilton Ohio United States 45011
    28 TCN Family Solutions Xenia Ohio United States 45385
    29 Seton Family of Hospitals Austin Texas United States 78712

    Sponsors and Collaborators

    • Melissa Delbello
    • Patient-Centered Outcomes Research Institute

    Investigators

    • Principal Investigator: Melissa P DelBello, MD, MS, University of Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Melissa Delbello, Principal Investigator, University of Cincinnati
    ClinicalTrials.gov Identifier:
    NCT02515773
    Other Study ID Numbers:
    • DelBello PCORI
    First Posted:
    Aug 5, 2015
    Last Update Posted:
    Feb 28, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Overweight
    Bipolar Disorder
    Metformin

    Study Results

    No Results Posted as of Feb 28, 2022