Metabolic Effect of Metformin in Obese Insulin Resistant Adolescents With Normal Glucose Tolerance

PHASE4CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
Pediatric ObesityInsulin ResistanceHyperinsulinemia
Interventions
DRUG

Metformin

"The subject will receive either metformin or placebo drug, given as 500mg tablets (or corresponding placebos) necessary to increase the dose incrementally over a three week period.~The time it takes to incrementally increase the dose to the desired dose of 500mg in am and 1000mg in pm will count as intervention time. Both the metformin and placebo group will also be given a multivitamin with vitamin B12 to avoid potential anemia."

DRUG

Placebo

"The subject will receive either metformin or placebo drug, given as 500mg tablets (or corresponding placebos) necessary to increase the dose incrementally over a three week period.~The time it takes to incrementally increase the dose to the desired dose of 500mg in am and 1000mg in pm will count as intervention time. Both the metformin and placebo group will also be given a multivitamin with vitamin B12 to avoid potential anemia."

Trial Locations (1)

06511

Yale Center for Clinical Investigation (YCCI), New Haven

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

lead

Yale University

OTHER

NCT00667498 - Metabolic Effect of Metformin in Obese Insulin Resistant Adolescents With Normal Glucose Tolerance | Biotech Hunter | Biotech Hunter