Metformin to Treat Obesity in Children With Insulin Resistance - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Hyperinsulinemia Obesity
Interventions:	Drug: Metformin HCL Drug: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We recruited subjects from 2000 through 2008. Obese children (BMI 95th percentile or greater), aged 6-12y, were recruited through newspaper advertisements and letters to physicians, and were eligible if they had fasting hyperinsulinemia, (insulin at least 15mU/mL. Following an outpatient screen, participants were admitted for assessments.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Children were excluded if they had impaired fasting glucose or were diabetic, had significant renal, hepatic, cardiac or pulmonary disease, or presence of other endocrinologic disorders leading to obesity, had used prescription or non-prescription weight loss agents, or reported >2% body weight loss in the preceding 6 months.

Reporting Groups

	Description
Metformin Plus Weight Reduction Counseling	Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
Placebo Plus Weight Reduction Counseling	Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program

Participant Flow: Overall Study

	Metformin Plus Weight Reduction Counseling	Placebo Plus Weight Reduction Counseling
STARTED	53	47
COMPLETED	45	40
NOT COMPLETED	8	7

Baseline Characteristics

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Reporting Groups

	Description
Metformin Plus Weight Reduction Counseling	Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
Placebo Plus Weight Reduction Counseling	Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program

Baseline Measures

	Metformin Plus Weight Reduction Counseling	Placebo Plus Weight Reduction Counseling	Total
Number of Participants [units: participants]	53	47	100
Age [units: participants]
<=18 years	53	47	100
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	10.1 ± 1.6	10.4 ± 1.4	10.2 ± 1.5
Gender [units: participants]
Female	30	30	60
Male	23	17	40
Region of Enrollment [units: participants]
United States	53	47	100

Outcome Measures

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1. Primary:

Changes in Body Weight as Determined by Body Mass Index-standard Deviation Score (BMI-SDS). [ Time Frame: 6 months ]

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2. Secondary:

Change in Body Weight as Determined by BMI [ Time Frame: 6 months ]

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3. Secondary:

Change in Body Weight [ Time Frame: 6 months ]

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4. Secondary:

Change in Body Fat by DEXA [ Time Frame: 6 months ]

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5. Secondary:

Change in Body Fat by Bod Pod [ Time Frame: 6 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Jack A. Yanovski, MD, PhD, Chief, Unit on Growth and Obesity
Organization: National Institute of Child Health and Human Development, NIH
phone: 301-496-0858
e-mail: yanovskj@mail.nih.gov

Publications:

Bao W, Srinivasan SR, Wattigney WA, Berenson GS. Persistence of multiple cardiovascular risk clustering related to syndrome X from childhood to young adulthood. The Bogalusa Heart Study. Arch Intern Med. 1994 Aug 22;154(16):1842-7.

Wilson DM, Abrams SH, Aye T, Lee PD, Lenders C, Lustig RH, Osganian SV, Feldman HA; Glaser Pediatric Research Network Obesity Study Group. Metformin extended release treatment of adolescent obesity: a 48-week randomized, double-blind, placebo-controlled trial with 48-week follow-up. Arch Pediatr Adolesc Med. 2010 Feb;164(2):116-23.

Melnik TA, Rhoades SJ, Wales KR, Cowell C, Wolfe WS. Overweight school children in New York City: prevalence estimates and characteristics. Int J Obes Relat Metab Disord. 1998 Jan;22(1):7-13.

Publications automatically indexed to this study:

Yanovski JA, Krakoff J, Salaita CG, McDuffie JR, Kozlosky M, Sebring NG, Reynolds JC, Brady SM, Calis KA. Effects of metformin on body weight and body composition in obese insulin-resistant children: a randomized clinical trial. Diabetes. 2011 Feb;60(2):477-85. Epub 2011 Jan 12.

Responsible Party:	Jack A. Yanovski, M.D./National Institute of Child Health and Human Development, National Institutes of Health
ClinicalTrials.gov Identifier:	NCT00005669 History of Changes
Other Study ID Numbers:	00-CH-0134, 00-CH-0134
Study First Received:	May 19, 2000
Results First Received:	April 7, 2010
Last Updated:	March 7, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration