search
Back to results

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

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metformin
healthy lifestyle intervention (LIFE)
Sponsored by
Melissa Delbello
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • The Children's Home of Northern Kentucky
  • Jersey Shore Medical Center
  • South Oaks
  • SUNY Downstate/ Kings County Hospital
  • Maimonides
  • NYCCC
  • Northwell Zucker Long Island Jewish Hospital
  • Mount Sinai
  • LIJ Zucker Hillside Hospital
  • Child Center of New York,
  • NorthShore Child and Family Guidance
  • StonyBrook
  • Lighthouse Youth Services
  • Central Clinic
  • Children's Home
  • Cincinnati Children's Hospital Medical Center
  • Resident Mood Medication Clinic
  • St. Aloysius
  • Talbert House
  • St. Joseph's Orphanage
  • Child Focus
  • NECCO
  • University Hospital Medical Center Cleveland
  • Nationwide Children's Hospital Columbus
  • Ohio State University
  • South Community
  • Butler Behavioral Health Services
  • TCN Family Solutions
  • Seton Family of Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MET and LIFE

Healthy lifestyle intervention (LIFE)

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

BMI z-score
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

Composite Metabolic Health and Nutrition Measure
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.

Full Information

First Posted
July 31, 2015
Last Updated
September 19, 2023
Sponsor
Melissa Delbello
Collaborators
Patient-Centered Outcomes Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02515773
Brief Title
Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs
Acronym
MOBILITY
Official Title
MOBILITY- Metformin for Overweight & OBese ChILdren and Adolescents With BIpolar Spectrum Disorders Treated With Second-Generation AntipsYchotics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
June 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Melissa Delbello
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1565 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MET and LIFE
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy lifestyle intervention (LIFE)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
GLUCOPHAGE
Intervention Description
Metformin - to achieves maximum insulin-sensitizing effects
Intervention Type
Behavioral
Intervention Name(s)
healthy lifestyle intervention (LIFE)
Other Intervention Name(s)
LIFE
Intervention Description
Healthy Life style intervention
Primary Outcome Measure Information:
Title
BMI z-score
Description
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.
Time Frame
Screen/Baseline to Visit 24
Secondary Outcome Measure Information:
Title
Composite Metabolic Health and Nutrition Measure
Description
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.
Time Frame
Screen/Baseline to Visit 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Inpatient or outpatient age 8-19 years inclusive; participants must live with a parent, guardian, or caregiver; Fluent in English; 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); Body mass index >85%ile for age and sex by standard growth charts; 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: 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa P DelBello, MD, MS
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Home of Northern Kentucky
City
Covington
State/Province
Kentucky
ZIP/Postal Code
41011
Country
United States
Facility Name
Jersey Shore Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
South Oaks
City
Amityville
State/Province
New York
ZIP/Postal Code
11701
Country
United States
Facility Name
SUNY Downstate/ Kings County Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Maimonides
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
NYCCC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11233
Country
United States
Facility Name
Northwell Zucker Long Island Jewish Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
LIJ Zucker Hillside Hospital
City
New York
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
Child Center of New York,
City
Queens
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
NorthShore Child and Family Guidance
City
Roslyn Heights
State/Province
New York
ZIP/Postal Code
11577
Country
United States
Facility Name
StonyBrook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Lighthouse Youth Services
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
Central Clinic
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Children's Home
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Resident Mood Medication Clinic
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
St. Aloysius
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45237
Country
United States
Facility Name
Talbert House
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45238
Country
United States
Facility Name
St. Joseph's Orphanage
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45239
Country
United States
Facility Name
Child Focus
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45244
Country
United States
Facility Name
NECCO
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
University Hospital Medical Center Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Nationwide Children's Hospital Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
South Community
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Butler Behavioral Health Services
City
Hamilton
State/Province
Ohio
ZIP/Postal Code
45011
Country
United States
Facility Name
TCN Family Solutions
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Seton Family of Hospitals
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs