Overview

Glaser Obesity Study

Status:
Unknown status
Trial end date:
2007-11-01
Target enrollment:
0
Participant gender:
All
Summary
This study will determine if the drug metformin, coupled with diet and exercise counseling, will help obese adolescents lose weight.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Boston Children’s Hospital
Glaser Pediatric Research Network
Collaborators:
Elizabeth Glaser Pediatric AIDS Foundation
Glaser Pediatric Research Network
Treatments:
Metformin
Criteria
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 (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 Criteria:

- 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