| Trial ID: | L3635 |
| Source ID: | NCT00005669
|
| Associated Drug: |
Metformin Hcl
|
| Title: |
Metformin to Treat Obesity in Children With Insulin Resistance
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00005669/results
|
| Conditions: |
Hyperinsulinemia|Obesity
|
| Interventions: |
DRUG: Metformin HCL|DRUG: Placebo
|
| Outcome Measures: |
Primary: Changes in Body Weight as Determined by Body Mass Index-standard Deviation Score (BMI-SDS)., Change in Body Mass Index standard deviation score (BMI-SDS) determined using tables created by the CDC in 2000. BMI-SDS is a unitless transformation of the body mass index (measured in kg divided by the squared height in meters) using the L M S method. Possible values range from -3 to +3. See http://www.cdc.gov/growthcharts/percentile_data_files.htm for details., 6 months | Secondary: Change in Body Weight as Determined by BMI, Change in body weight as determined by body mass index (kg/m2), 6 months|Change in Body Weight, Change in body weight (kg), 6 months|Change in Body Fat by DEXA, Change in body fat mass by Dual Energy X-Ray Absorptiometry (kg), 6 months|Change in Body Fat by Bod Pod, Change in body fat mass measured by air displacement plethysmography (kg), 6 months
|
| Sponsor/Collaborators: |
Sponsor: Jack Yanovski, M.D. | Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE2
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2000-05
|
| Completion Date: |
2011-05
|
| Results First Posted: |
2011-04-07
|
| Last Update Posted: |
2015-05-08
|
| Locations: |
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00005669
|
