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Two studies testing new weight-loss
by Mary Helen
Two studies under way in MUSC’s Weight Management Center are testing a
new drug aimed at reducing appetite as a way to prevent and treat
diseases related to obesity.
Both studies are recruiting participants for the year-long trial of
lorcaserin, developed by San Diego-based Arena Pharmaceuticals, which
also is sponsoring the studies.
“These studies combine the use of an investigational medication,
developed for use as a possible weight-loss therapy, with a
behaviorally-based lifestyle change program to help participants make
long-term diet and activity changes,” said Patrick O’Neil, Ph.D.,
Weight Management Center director. “The medication is being studied to
learn whether it will help participants reduce their calorie intake.”
The drug activates a subtype of serotonin receptor in the brain that is
involved with the regulation of appetite and food intake. “These trials
are designed to learn whether this will result in improved weight
loss,” O’Neil said.
The drug does not alter a person’s taste of food or energy expenditure,
O’Neil explained. MUSC is one of about 100 centers studying the safety
and efficacy of the drug for weight loss.
The drug has shown promise in animal trials and in very early human
trials, O’Neil said, which warrants further investigation. It currently
is not approved by the Food and Drug Administration, and is one of a
number of drugs being tested for this purpose.
One of the two trials focuses on people with type 2 diabetes and will
involve monitoring not only changes in weight but also blood sugar
control. The other weight loss trial is for people who do not have type
2 diabetes and who are generally healthy. Other health factors related
to obesity will be measured in both studies.
Previous studies have shown that even modest weight loss, such as 10
percent of initial weight (e.g., a 20-pound loss for a 200-pound
person) can help many overweight diabetics improve their blood sugar
control. It may also help to prevent diabetes. In one landmark study,
overweight people at risk for diabetes who lost about 7 percent of
their start weight had a 58 percent lower rate of developing diabetes
during the next four years.
In the study for individuals with type 2 diabetes, the center is hoping
to recruit between 10 and 20 participants. In the second study,
researchers are seeking up to 40 participants.
In general, these studies will last about a year. Participants will
have a health screening, attend at least 17 clinic visits at the
center, and have three visits for an echocardiogram at a facility in
the Charleston area.
Participants will either receive the drug or placebo twice a day
throughout the duration of the study.
Once accepted into the study, participants will receive weight
management counseling (diet, physical activity, behavior modification)
at every visit. At various visits throughout the study, participants
can expect the following procedures: a physical exam, blood draws,
urine collections, electrocardiograms, echo-cardiograms, oral
interview, measurement of vital signs, weight, height, and waist, and
the completion of questionnaires.
To receive more information, call the Weight Management Center at
792-5577. State whether you are inquiring about the study for
diabetics or the one for non-diabetics. For faster receipt of
information, send an e-mail to firstname.lastname@example.org with “Study D” in the
subject line for the diabetic study or “Blue Study” in the subject line
for the non-diabetic study.
Friday, April 25, 2008
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