ZAC: Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00617058
• Collaborator: Foundation of Hope, North Carolina (Other)
• Enrollment: 1
• Location: 1
• Arms: 3
• Duration (Months): 42.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the relative risks and benefits of two approaches to the control of weight gain and other negative side effects in children and adolescents on 2nd generation antipsychotics (SGA):

• Healthy lifestyle instruction (nutritional and physical activity surveillance and advice) + continuation of current SGA;

• Add the diabetes drug, metformin + continuation of current SGA.

Condition or Disease	Intervention/Treatment	Phase
Weight Gain	Drug: metformin; Behavioral: healthy lifestyle intervention	Phase 2

Detailed Description

The proposed pilot study is being conducted to obtain pilot data to support a grant application for a multi-site randomized controlled trial. The primary objective is to evaluate the relative risks and benefits of two approaches to the control of weight gain and other negative side effects in children and adolescents on 2nd generation antipsychotics (SGA). The critical question being addressed is: What can be done for the many youth who have gained substantial weight or developed high levels of lipids or glucose in their blood on an SGA; but due to their illness require continued treatment with an antipsychotic?

At least 40 youths (and no more than 60) age 10-17 that have gained substantial weight while taking a frequently used SGA: ziprasidone, aripiprazole or clozapine will be randomized to one of two treatments for 6 months:

• Healthy lifestyle instruction (nutritional and physical activity surveillance and advice) + continuation of current SGA;

• Add the diabetes drug, metformin + continuation of current SGA.

• Subjects may also elect to be in an observational arm that involves no intervention but the same major assessments.

Height, weight, body fat, and various blood tests indicative of general health will be collected during the 6 month trial to monitor the health benefits and safety of the interventions.

SGAs are associated with concerning degrees of weight gain and metabolic consequences. Children and adolescents, in whom SGAs are used increasingly for a wide variety of conditions, are particularly vulnerable to these side effects, which adversely affect health and longevity. It is imperative that researchers evaluate the efficacy and safety of interventions designed to prevent and treat the weight gain and metabolic problems caused by antipsychotic treatment of children. Lifestyle interventions and adjunctive medications all hold some promise of efficacy. However, it is essential that these strategies be rigorously evaluated as soon as possible in order to prevent the ongoing health consequences of SGA treatment in another generation of children with serious psychiatric illnesses.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.	Drug: metformin; open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID; Other Names: Glucophage
Experimental: 2 Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors	Behavioral: healthy lifestyle intervention; additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.
No Intervention: 3 Self-selected patients will be followed at major timepoints to assess weight and related measures.

Outcome Measures

Primary Outcome Measures

1. Percent Change in BMI [24 weeks]

2. Absolute Change in Weight [24 weeks]

3. Percent Change in Fat Mass [24 weeks]

4. Percent Change in Weight [24 weeks]

Secondary Outcome Measures

1. Percent Change in Insulin Levels [24 weeks]

2. Percent Change in Total Cholesterol [24 weeks]

3. Percent Change in Triglycerides [24 weeks]

4. Incidence of Metabolic Syndrome [24 weeks]

5. Percent Change in Glucose Levels [24 weeks]

6. Percent Change in HDL [24 weeks]

7. Percent Change in LDL [24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ages 10 to 17 years (inclusive).

• Receiving treatment with ziprasidone, aripiprazole or clozapine for the past 56 days or longer.

• Clinically stable on current treatment regimen (see Rationales below).

• Stable dose of current psychotropic co-medications for at least 30 days.

• BMI increase of > 7% within 3 months OR a > 0.5 BMI z-score increase within the past 24 months while taking olanzapine, quetiapine or risperidone, with maintenance of the threshold level of weight gain.

• Lifetime diagnosis of a schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder, psychotic disorder NOS), a bipolar spectrum disorder (bipolar disorder, bipolar disorder NOS), certain mood disorders (mood disorder NOS, major depressive disorder with psychotic features), or certain disruptive/aggressive disorders (conduct disorder, intermittent explosive disorder, autism spectrum disorder with history of clinically significant levels of disruptive behaviors as defined below) using DSM-IV criteria determined by clinical interview and K-SADS-PL.

• Sexually active girls must agree to use an effective form of birth control or be abstinent.

• Principle caretaker is able to participate in study appointments as is clinically indicated.

• guardian and the child must agree (legally consent and assent) to participation.

Exclusion Criteria:

• Any medication that would significantly alter glucose, insulin or lipid levels. Prohibited medications will include, but are not limited to: insulin, steroids, topiramate, sibutramine, orlistat, metformin, amantadine, vitamin E (other than in standard multivitamins), antidiabetic drugs, HIV drugs.

• Major neurological disorder or medical illness that affects weight gain (e.g., unstable thyroid disease), requires a prohibited systemic medication or procedure (e.g., diabetes mellitus [insulin], chronic renal failure [steroids]) or that would prevent participation in physical activity in the healthy lifestyle program.

• Current active thyroid (TSH >18 microIU/ml), hepatic (2 LFTs >4x upper limits of normal), renal (serum Creatinine >1.4 mg/dL in females and serum Creatinine >1.5 mg/dL in males), cardiac, gastrointestinal, or adrenal disease.

• Fasting glucose > 125 mg/dL on two occasions indicating need for prompt treatment for diabetes.

• Child meets DSM-IV criteria for substance abuse or dependence disorder within the past month, not including tobacco abuse or dependence • Current treatment with more than one antipsychotic medication.

• Current treatment with more than 5 total psychotropic medications (i.e., 4 psychotropics plus SGA).

• Known hypersensitivity to metformin.

• Pregnant or breast feeding.

• Current or lifetime diagnosis of anorexia nervosa or bulimia nervosa.

• Significant risk for dangerousness to self or to others that makes participating inadvisable.

• Language issues that prevent child and/or parent from completing assessments or treatment.

• Ongoing or previously undisclosed child abuse requiring new department of social service intervention.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina, Department of Psychiatry	Chapel HIll	North Carolina	United States	27599

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• Foundation of Hope, North Carolina

Investigators

• Principal Investigator: Linmarie Sikich, MD, University of North Carolina, Department of Psychiatry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Linmarie Sikich, MD, Associate Professor of Psychiatry, University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT00617058
• Other Study ID Numbers: 05-3110 GCRC-2529
• First Posted: Feb 15, 2008
• Last Update Posted: Dec 31, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Linmarie Sikich, MD, Associate Professor of Psychiatry, University of North Carolina, Chapel Hill: antipsychotic; metformin; children; adolescents
• Additional relevant MeSH terms: Weight Gain; Metformin

Study Results

Participant Flow

Recruitment Details	Potential subjects will be identified through referrals that the research program receives for other clinical trials involving the same age population with similar diagnoses. We also plan to access PHI to identify potential subjects and use MIM and the ISD helpdesk to complete hospital review of individuals ages 10-17 taking an antipsychotic.
Pre-assignment Detail	Randomization will be completed using computer generated randomization schedules. In order to preserve adequate sample sizes in the cells, important variables such as pubertal status, concomitant valproic acid, concomitant stimulants, gender, race (Asian/Caucasian vs. Other), and ethnicity (Hispanic/Non-Hispanic) will be examined as covariates.

Arm/Group Title	Co-Treatment With Metformin	Healthy Lifestyle Instruction Group	Elective Monitoring Control Group
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID	Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.	For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
Period Title: Overall Study
STARTED	1	0	0
COMPLETED	1	0	0
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Co-Treatment With Metformin	Healthy Lifestyle Instruction Group	Elective Monitoring Control Group	Total
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID	Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.	For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.	Total of all reporting groups
Overall Participants	1	0	0	1
Age (participants) [Number]
<=18 years	1 100%	1 Infinity
Between 18 and 65 years	0 0%	0 NaN
>=65 years	0 0%	0 NaN
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	17	17
Gender (participants) [Number]
Female	0 0%	0 NaN
Male	1 100%	1 Infinity
Region of Enrollment (participants) [Number]
United States	1 100%	1 Infinity

Outcome Measures

1. Primary Outcome

Title	Percent Change in BMI
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

This research study only enrolled a single study participant before the entire research study was terminated due to the start of a larger, multi-site trial evaluating similar outcome measures.

Arm/Group Title	Co-Treatment With Metformin	Healthy Lifestyle Instruction Group	Elective Monitoring Control Group
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID	Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.	For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
Measure Participants	1	0	0
Number [percent change]	-2.65

2. Primary Outcome

Title	Absolute Change in Weight
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Co-Treatment With Metformin	Healthy Lifestyle Instruction Group	Elective Monitoring Control Group
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID	Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.	For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
Measure Participants	1	0	0
Number [lbs.]	-10.6

3. Primary Outcome

Title	Percent Change in Fat Mass
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Co-Treatment With Metformin	Healthy Lifestyle Instruction Group	Elective Monitoring Control Group
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID	Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.	For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
Measure Participants	1	0	0
Number [percent change]	3.80

4. Secondary Outcome

Title	Percent Change in Insulin Levels
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Co-Treatment With Metformin	Healthy Lifestyle Instruction Group	Elective Monitoring Control Group
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID	Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.	For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
Measure Participants	1	0	0
Number [percent change]	-23.08

5. Secondary Outcome

Title	Percent Change in Total Cholesterol
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Co-Treatment With Metformin	Healthy Lifestyle Instruction Group	Elective Monitoring Control Group
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID	Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.	For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
Measure Participants	1	0	0
Number [percent change]	2.84

6. Secondary Outcome

Title	Percent Change in Triglycerides
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Co-Treatment With Metformin	Healthy Lifestyle Instruction Group	Elective Monitoring Control Group
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID	Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.	For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
Measure Participants	1	0	0
Number [percent change]	46.60

7. Secondary Outcome

Title	Incidence of Metabolic Syndrome
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Co-Treatment With Metformin	Healthy Lifestyle Instruction Group	Elective Monitoring Control Group
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID	Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.	For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
Measure Participants	1	0	0
Number [participants]	0 0%

8. Primary Outcome

Title	Percent Change in Weight
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Co-Treatment With Metformin	Healthy Lifestyle Instruction Group	Elective Monitoring Control Group
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID	Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.	For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
Measure Participants	1	0	0
Number [percent change]	-4.00

9. Secondary Outcome

Title	Percent Change in Glucose Levels
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Co-Treatment With Metformin	Healthy Lifestyle Instruction Group	Elective Monitoring Control Group
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID	Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.	For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
Measure Participants	1	0	0
Number [percent change]	-3.41

10. Secondary Outcome

Title	Percent Change in HDL
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Co-Treatment With Metformin	Healthy Lifestyle Instruction Group	Elective Monitoring Control Group
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID	Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.	For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
Measure Participants	1	0	0
Number [percent change]	7.04

11. Secondary Outcome

Title	Percent Change in LDL
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Co-Treatment With Metformin	Healthy Lifestyle Instruction Group	Elective Monitoring Control Group
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID	Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.	For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
Measure Participants	1	0	0
Number [percent change]	-5.74

Adverse Events

Time Frame	Adverse event data were collected for the duration of the research study, which was a 6-month period.
Adverse Event Reporting Description	The study only enrolled one patient who was diagnosed with Major Depressive Disorder. The subject completed all 24 weeks of study treatment and was randomly assigned to the co-treatment with metformin arm. The single study participant began treatment at dose of 1500mg for 1 week, and then maintained dose of 2000mg for remainder of study.
Arm/Group Title	Co-Treatment With Metformin		Healthy Lifestyle Instruction Group		Elective Monitoring Control Group
Arm/Group Description	metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID		Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors.		For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
All Cause Mortality
	Co-Treatment With Metformin		Healthy Lifestyle Instruction Group		Elective Monitoring Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Co-Treatment With Metformin		Healthy Lifestyle Instruction Group		Elective Monitoring Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Co-Treatment With Metformin		Healthy Lifestyle Instruction Group		Elective Monitoring Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

In terms of study limitations, this research study was only able to enroll a single study participant before the trial was terminated prematurely due to study start-up for a larger, multisite effort examining similar outcome measures.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.