October 17, 2000
A study under way at the University of Alabama at Birmingham (UAB) aims to determine if Xenical, a proven weight-loss drug for adults, may also help adolescents who are severely overweight. This is the first weight-loss drug to be tested in adolescents.
"Today, 20 percent of adolescents are obese," says Dr. Frank Franklin, professor of pediatrics at UAB. "It is real problem that is not just cosmetic. Obese teenagers tend to have low self-esteem and attain less educationally and socio-economically. Also, we're seeing more serious medical complications, such as diabetes, in adolescents with obesity."
The multi-center study will recruit 450 patients to evaluate whether the drug is effective and safe in helping adolescents lose weight. UAB will enroll 15 adolescents. Participants must be between the ages of 12 and 16 and severely overweight to qualify for the study. "The drug isn't intended for people who are slightly overweight, but for those who have 50 to 90 pounds to lose," Franklin says.
Following a screening and initial exam, two-thirds of the teens will receive Xenical to take three times daily, once before each meal. Others will receive a placebo. Xenical, an oral medication, works by blocking about one-third of the fat ingested. "It requires changing your diet and limiting the amount of fatty foods you eat, or there is a possible side effect of loose stool," Franklin says.
Over the course of the 52-week study, the teens will visit the clinic 21 times. "Although not all adolescents will receive the drug, all will receive physician exams and nutritional counseling at no charge," Franklin says. "Most insurance companies don't cover weight-loss programs, which can be very expensive. So for those who qualify and wish to participate, it is a real cost saver."