Status:
UNKNOWN
Glaser Obesity Study
Lead Sponsor:
Glaser Pediatric Research Network
Collaborating Sponsors:
Elizabeth Glaser Pediatric AIDS Foundation
Conditions:
Obesity
Eligibility:
All Genders
13-18 years
Phase:
PHASE2
PHASE3
Brief Summary
This study will determine if the drug metformin, coupled with diet and exercise counseling, will help obese adolescents lose weight.
Detailed Description
America is facing an epidemic of obesity among its youth. In the last seven years, there has been a 50% increase in the prevalence of obesity as defined by a Body Mass Index (BMI) \> 30 kg/m². For the...
Eligibility Criteria
Inclusion
- 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 (see Appendix), but must weigh less than 300 pounds (\<136 kilograms) when measured during the initial physical exam at week 0 (Baseline). BMI will be calculated as follows; weight in kilograms \[height in meters\]2. This cutoff has been established due to the weight-bearing limits of the table used in performing the DXA scan. Once enrolled, if a subject's weight progresses above 300 pounds, s/he may continue in the study whether it is possible to perform DXA or not.
- Completion of informed consent/assent process
Exclusion
- Known diabetes as defined by the American Diabetes Association criteria
- Prior drug therapy to treat diabetes or insulin insensitivity, including any form of insulin or insulin analogs; or any oral antidiabetic medication; acarbose, acetohexamide, chlorpropamide, glimepiride, glipizide, glyburide, metformin, pioglitazone, repaglinide, rosiglitazone, tolazamide, tolbutamide or troglitazone.
- Prior use of drugs to aid in weight loss, including but not limited to: Benzphetamine Hcl, Diethylpropion Hcl, Fenfluramine Hcl, Phendimetrazine Tartrate, Phentermine Hcl, Orlistat, Sibutramine Hcl Monohydrate, Didrex, Tenuate, Pondimin, Bontril-SR, Adipex-P, Fastin, Ionamin, Phentrol, Xenical, Meridia.
- 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.
- Subjects will be excluded from the study if they have taken prescription-strength glucocorticoids (by any route) within three months of the screening visit. Topical glucocorticoids are acceptable if their strength is no greater than the equivalent of 1% hydrocortisone cream.
- History of any syndrome or medical disorder associated with significant obesity, including but not limited to: Prader Willi Syndrome, Bardet-Biedl Syndrome, Cohen Syndrome, Cushing syndrome or disease.
- Prior surgical therapy for obesity
- Subject to be excluded if s/he has attended a formal weight loss program within 6 months prior to the Screening visit.
- In the 6 months prior to Screening, subject has consumed alcohol more frequently than twice per week and/or subject has had more than three alcohol-containing beverages in a 24 hour period.
- 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)
- 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
- Previous pregnancy
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00209482
Start Date
October 1 2003
End Date
November 1 2007
Last Update
October 5 2006
Active Locations (5)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Stanford University
Stanford, California, United States, 94305
4
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115