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| Sponsor: | Children's Hospital Boston |
|---|---|
| Collaborators: |
Glaser Pediatric Research Network Elizabeth Glaser Pediatric AIDS Foundation |
| Information provided by: | Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT00120146 |
Purpose
This trial will test the hypothesis that among obese adolescents, treatment with extended-release metformin (Glucophage® XR), coupled with a lifestyle intervention, will result in decreased obesity (as measured by body mass index [BMI]) as compared to subjects who receive treatment with placebo and the same lifestyle intervention.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: Metformin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Educational/Counseling/Training |
| Official Title: | A Multi-Center, Randomized, Placebo Controlled, Double- Blind Trial of Metformin in Obese Adolescents |
| Estimated Enrollment: | 22 |
| Study Start Date: | October 2002 |
Eligibility| Ages Eligible for Study: | 13 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded from the study for any of the following:
cimetidine, amiloride, digoxin, furosemide, morphine, nifedipine, procainamide, ranitidine, triamterene, trimethoprim, vancomycin and quinidine, as these medications may increase metformin levels.
An AST or ALT of > 2 times upper limit of normal was chosen based on data which show that approximately 5% of obese adolescents have liver enzymes greater than 2 times the upper limit of normal in the clinical setting.
Contacts and Locations| United States, Massachusetts | |
| Children's Hospital, Boston | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Carine Lenders, MD | Children's Hospital Boston |
More Information
| ClinicalTrials.gov Identifier: | NCT00120146 History of Changes |
| Other Study ID Numbers: | 05-09-132R |
| Study First Received: | July 7, 2005 |
| Last Updated: | January 17, 2006 |
| Health Authority: | United States: Institutional Review Board |
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |