This trial is active, not recruiting.

Condition obesity
Treatment metformin
Phase phase 3
Sponsor Children's Hospital Boston
Collaborator Glaser Pediatric Research Network
Start date October 2002
Trial size 22 participants
Trial identifier NCT00120146, 05-09-132R


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double-blind
Primary purpose educational/counseling/training

Primary Outcomes

Change in BMI
time frame:
Body mass index (BMI)
time frame:

Secondary Outcomes

Change in insulin sensitivity
time frame:
Fasting insulin concentrations
time frame:
Characterization of insulin dynamics and insulin sensitivity
time frame:
Characterization of fat distribution and fatty infiltration of the liver
time frame:
Use of CT to characterize abdominal fat distribution
time frame:
Use of CT and ALT levels to assess fatty infiltration of the liver
time frame:
Characterization of body composition
time frame:
Characterization of dietary amino acids
time frame:
Characterization of the insulin/glucagon ratio
time frame:
Characterization of the impact of gender on response to metformin XR
time frame:
Characterization of the impact of race/ethnicity on response to metformin XR
time frame:
Characterization of health-related quality of life
time frame:

Eligibility Criteria

Male or female participants from 13 years up to 17 years old.

Inclusion Criteria: - Subjects must be between the ages of 13.00 and 17.99 at week 0 (Baseline) - Subjects must have a BMI > 95th percentile for age and gender using the CDC data, and must weigh less than 300 pounds (< 136 kilograms) at week 0 (Baseline) - Completion of informed consent/assent process Exclusion Criteria: Subjects will be excluded from the study for any of the following: - Known diabetes as defined by the American Diabetes Association criteria. - Prior drug therapy to treat diabetes or insulin insensitivity - Has ever used a medication to aid in weight loss - Subject is currently taking the following medications at the time of the Screening visit: cimetidine, amiloride, digoxin, furosemide, morphine, nifedipine, procainamide, ranitidine, triamterene, trimethoprim, vancomycin and quinidine, as these medications may increase metformin levels. - Recent glucocorticoid therapy - History of any syndrome or medical disorder associated with significant obesity - Recent history of involvement in a formal weight loss program - Alcohol use - Elevated creatinine (> 1.2 mg/dl) - Untreated disorders of thyroid function - Elevated liver enzymes (Alanine Aminotransferase [ALT] or Aspartate Aminotransferase [AST]) > 80 (approximately 2 times upper limit of normal). 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. - Mobility impairment that prevents full participation in recommended physical activity - Other serious medical condition that the Principal Investigator or Lead Site Investigator determines may put the patient at undue risk if enrolled in the study - Unable to comply with the protocol in the opinion of the Principal Investigator or the Lead Site Investigator - Subjects with child-bearing potential who are unwilling to remain abstinent or use an effective method of birth control. Females who have had at least one menstrual cycle must either be abstinent or must consistently be using an effective method of birth control (e.g., intrauterine contraceptive device, oral contraceptive or medroxyprogesterone acetate or barrier method [diaphragm or condom] plus contraceptive jelly, cream, or foam) during the study. This will be documented at each visit. Additionally, all females who have begun menstruating must have a negative result on the urine pregnancy test administered at every visit in order to remain on study drug and undergo radiologic procedures. - Previous pregnancy

Additional Information

Official title A Multi-Center, Randomized, Placebo Controlled, Double- Blind Trial of Metformin in Obese Adolescents
Principal investigator Carine Lenders, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2006.
Information provided to ClinicalTrials.gov by Children's Hospital Boston.