May 13, 2008
UC San Diego Researchers Looking for Investigational Drug Study Participants
Slow, Steady Pace Wins the Weight Race
Obesity is no longer simply a health concern. It’s an alarming epidemic. In just the last two decades, the number of obese and overweight people in the United States has more than doubled. Obesity and overweight are major risk factors for life-threatening diseases such as type 2 diabetes, heart attack, stroke, and many forms of cancer.
University of California, San Diego School of Medicine researchers are taking part in two nationwide studies to determine whether an investigational drug, lorcaserin hydrochloride, can help overweight or obese men and women, with or without type 2 diabetes, lose weight.
“This program is interesting to me because it has reasonable goals,” said Elizabeth Barrett-Connor, M.D., distinguished professor and Division Chief of Epidemiology in the Department of Family and Preventive Medicine at the UC San Diego School of Medicine. “The goal is to reduce body fat by five percent over one year, which is a slow, steady pace that’s reasonable to achieve and to maintain. Our earlier Diabetes Prevention Program trial found that obese and overweight people who lost five percent of their body weight reduced their risk for diabetes by 53 percent. That’s life changing.”
Nearly 5000 patients will be enrolled at approximately 100 study sites across the United States. The UC San Diego Prevention Studies clinic on the La Jolla campus seeks 25-30 participants for each study.
Who Can Participate?
Study participants must be:
- Men and women between the ages of 18 and 65 years old
- Overweight or obese
- Without diabetes or,
- Previously diagnosed with type 2 diabetes and managed with oral diabetes medications
- Able to participate in full 52-week study, attending up to 17 clinic visits
Participants will receive either lorcaserin or placebo in a 2 to 1 ratio (2 out of every 3 participants will receive the lorcaserin). Everyone will participate in a diet and exercise program designed specifically for the studies. Enrollees will meet with a dietician/counselor for guidance through healthy eating and activity schedules designed for each individual.
“Even a small but sustained weight loss can have a huge benefit. Yo-yo weight loss and gain is not healthy. In this trial, we include counseling about a healthier diet, portion control, and the kinds and amount of physical activity that will truly help,” said Barrett-Connor. “Whether or not the participant receives the drug or the placebo, this comes with an attractive lifestyle package, including consultation with counselors, staff visits and phone calls.”
Interested participants can call the recruitment coordinator at (858)822-5844.
Lorcaserin is being developed to treat obesity and is meant to be used along with diet and exercise. It is an appetite suppressant similar to fenfluramine and dexfenfluramine, which were pulled from the U.S. market in 1997 due to safety concerns.
Lorcaserin was designed to decrease appetite without the side effects associated with these earlier drugs. Because the cause of the side effects was not fully understood, researchers cannot be certain that the harmful effects caused by earlier drugs have been eliminated. At the present time we can say that these two studies will be the tenth and eleventh in humans. More than 4,300 volunteers have participated in studies of lorcaserin, ranging from single doses to 52 weeks of dosing.
About Elizabeth Barrett-Connor, M.D.
Elizabeth Barrett-Connor, M.D., is a Distinguished Professor and Division Chief of Epidemiology in the Department of Family and Preventive Medicine at the UC San Diego School of Medicine. Her pioneering work spans many areas including cardiovascular disease, diabetes, cancer, osteoporosis, memory loss and exogenous and endogenous hormones.
Barrett-Connor is founder and director of the Rancho Bernardo Heart and Chronic Disease Study, begun in 1972, with continuous support from the NIH. She is/was principal investigator of several multi-center clinical trials including the Postmenopausal Estrogen/Progestin Interventions (PEPI) study, the Heart and Estrogen-Progestin Replacement Study (HERS), the Raloxifene Use in The Heart (RUTH) study, and Diabetes Prevention Program Follow-up Study (DPPOS).
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