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Ambitious clinical trial test program to prevent diabetes among Latinos in Lawrence

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Story - Ambitious Ira S. Ockene, MD

Many clinical trials at UMass Medical School have a community impact. This trial, featured in the UMMS magazine Vitae, introduces weight control, nutrition and exercise programs to a population at high risk for developing diabetes, with implications for all.

Elliot Joslin, founder of the famed diabetes  clinic that bears his name, said nearly 100 years ago that with diabetes, genetics loads the cannon, but obesity pulls the trigger. Today, among the Latino population of the United States, the cannons of diabetes are booming.

To address the soaring incidence of diabetes among Latinos, both in the commonwealth and across the country, UMass Medical School and the Greater Lawrence Family Health Center (GLFHC) have embarked on an ambitious clinical trial to test a program that researchers hope will prevent the onset of type 2 diabetes among members of the Latino population in Lawrence, Massachusetts. And if the trial succeeds there, it could point the way to a cost-effective approach for preventing type 2 diabetes in all populations.

“If we show that we can prevent diabetes among Latinos in Lawrence, then I would hope third-party payers would start covering this kind of intervention for anyone who needs it,” said Ira S. Ockene, MD, principal investigator of the clinical trial and the David J. and Barbara D. Milliken Professor of Preventive Cardiology and professor of medicine at UMMS. “Right now third-party payers are willing to pay $50,000 to have stents placed in your heart when you are sick, but they’re not willing to pay $1,000 for the counseling that might prevent you from becoming sick. That’s unfortunate, and I hope if our study is successful, that will change.”

Dr. Ockene’s reference to heart disease in the context of a diabetes prevention program is hardly casual. The consequences of diabetes left unchecked are severe, including heart disease, stroke, blindness and kidney failure. “Diabetes is an extraordinary risk factor for heart disease,” Ockene said. “The major cause of death among diabetics is heart disease. So as a cardiologist, I have every reason to be interested in diabetes, just as I have every reason to be interested in smoking, high blood pressure and cholesterol.”

Conversely, diabetes can be managed with great success. Well understood measures, such as weight control, proper nutrition and increased physical activity can help most diabetics avoid the severe complications of the disease. So Ockene and his colleagues will attempt to translate that body of knowledge to help people who do not yet have diabetes remain free of the disease. “Based on all the studies we have done previously on how you get people to change their nutrition and physical activity, we believe we can develop an intervention that will be simple and workable in the real world—even in a very challenging environment like the one in Lawrence,” said Ockene.

John P. Mordes, MD, professor of medicine, a diabetes researcher and clinician at UMMS, worked as a consultant with Ockene to craft the clinical trial. “I see many Latinos in my clinic, so I know first-hand the magnitude of this problem,” Dr. Mordes said. “The goal of intervening before diabetes is present is, by far, preferable to providing care for someone who already has the disease. So it was a privilege for me to be asked by Dr. Ockene to be involved in the design of this trial.”

The effort is called the Lawrence Latino Diabetes Prevention Project (LLDPP), a four-year, $2.6 million randomized clinical trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health (NIH). The study brings together an array of community groups including the Lawrence Council on Aging/Senior Center, which will be the host site for much of the programming; the YWCA of Greater Lawrence, which will help with recruitment and advise on community issues; UMass Lowell, which will analyze the blood samples from participants in the study; and the clinical and research resources of UMass Medical School and the GLFHC.

“This is an excellent partnership between the academic researchers and the community,” said Trinidad Tellez, MD, a clinician-researcher at the GLFHC, and assistant professor of family medicine & community health at UMMS. Dr. Tellez is a co-principal investigator of the prevention study. She’s also a member of the Executive Advisory Committee for the Massachusetts Diabetes Prevention and Control Program, which is working on a statewide diabetes action plan. “The burden of diabetes in Lawrence is high and there are a lot of challenges delivering this intervention,” Tellez said. “We believe that if we can prevent diabetes here, anybody should be able to do it anywhere.”

According to the American Diabetes Association (ADA), some 18 million Americans now have type 2 diabetes (often called adult onset diabetes, though the spike in obesity among children is driving a similar increase in diabetes among young people). More troubling is the rate of increase in the prevalence of the disease. According to federal statistics, the number of people diagnosed with type 2 diabetes jumped nearly 30 percent between 1997 and 2002.

While type 2 diabetes affects all segments of the population, it hits certain groups harder. Latinos, Asians, African Americans and Native Americans are genetically more susceptible to diabetes, and that predisposition is enhanced by environmental or behavioral factors such as poverty and obesity that can hasten onset of the disease.
The result: these minority groups suffer from diabetes at two to three times the rate of the majority population in the United States. In Massachusetts, the prevalence of type 2 diabetes among Latinos is 8.4 percent, compared to 4.7 percent for the Caucasian population.

In Lawrence, one of the poorest communities in the commonwealth, the problem is even worse, with the prevalence rate now pegged at 11.8 percent for Latinos of Puerto Rican and Dominican origin. “There’s a confluence of factors here that add up to diabetes being much worse for Latinos in Lawrence,” Tellez said.

As it tracked the soaring incidence of type 2 diabetes in Lawrence, the GLFHC began working several years ago to help patients better manage their diabetes. Funded by a REACH 2010 grant from the U.S. Centers for Disease Control and Prevention, the health center developed educational and clinical protocols aimed at diabetic Latinos. Under the leadership of Dean Cleghorn, EdD, associate professor of family medicine & community health and a director of one of the GLFHC clinics, the REACH program has built an infrastructure of diabetes education and care within the health center. A cornerstone of that effort is the Diabetes Self-Management Education Program that was recently awarded “Education Recognition” from the ADA. “REACH is very important and very successful,” said Tellez, who also works on the REACH project. “We know it helps people who have diabetes. Now we’re trying to expand our scope and help the 42,000 Latinos in Lawrence who don’t have the disease, but who are at risk for developing diabetes.”

The Lawrence study will enroll a total of 400 Latinos who fall into this category. The participants will be split into two groups of 200 each, with one group (the control group) being given the usual care for non-diabetics now practiced in the Lawrence area.

The other group (the intervention group) will participate in a 23-month-long series of programs designed by the research team to help reduce the risk of developing diabetes—primarily through weight loss and increased physical activity. Both groups will be followed for a year after the intervention classes end.

The preventive programs for the group will include cooking classes, exercise classes, strategies for food shopping and eating out at restaurants. There will be educational sessions about diabetes, the risk factors that lead to diabetes, and the consequences of the disease if left unchecked. The program will also include several psychosocial elements to help people deal with issues such as self-efficacy and depression that play a pivotal role in a person’s ability to change behaviors. “Long-term adherence is the key to the success of this program,” said Milagros C. Rosal, PhD, associate professor of medicine at UMMS and co-principal investigator of the study. “When you want people to change, you have to make the changes easy and appealing, otherwise they won’t adhere to them long-term. So we will try to build skills in situations that resemble their day-to-day activity.”

Dr. Rosal works in the UMMS Division of Preventive and Behavioral Medicine. In the Lawrence study, Rosal will lead the effort to develop the programs that will convey the educational information on diabetes prevention to the intervention group. She will also develop practical literacy- and culturally sensitive strategies to facilitate attitudinal and behavioral change. “The Lawrence population presents multiple challenges, including language, culture and literacy level,” Rosal said. “We’ll need to use very little printed material, and we’re planning to deliver the entire intervention in Spanish.”

In that effort, Rosal will draw on insights she’s gleaned from several years of work studying factors that facilitate or inhibit diabetes self-management among low-literate Latinos. That population typically suffers higher complication rates and higher death rates from diabetes as compared to Caucasians, Rosal said.

“Interestingly, we found that the problem was not access to health care; nearly everyone in the groups we studied had access to health care and was seeing their doctor several times a year. So the key issue, I believe, is that patients may not be receiving the information they need about diabetes in ways they could process and integrate into their daily lives.”

Rosal is now working closely with clinicians, nutritionists and counselors from UMMS and the GLFHC to finalize the methods and materials to be used in the Lawrence clinical trial. Plans call for a variety of group sessions, individual sessions, and follow-up phone calls to participants’ homes. Recruitment for the study will begin this fall, and the first intervention classes are scheduled for January 2005.

Throughout the study, researchers will track participants’ weight, body/mass index, blood pressure, cholesterol and blood glucose levels. That data will be used in a well-established formula that can predict a person’s chance of developing diabetes within seven years, based on their metabolic profile. The test of the Lawrence study will be to see if the intervention group significantly reduces its risk of diabetes, compared to the control group. “Years ago when we studied cholesterol and heart attacks, we had to track people and prove we reduced the incidence of heart attacks in the group. We don’t do that anymore because the linkage is a given—now we just focus on reducing cholesterol, knowing that will reduce heart attacks,” Ockene said. “The same is true with diabetes. We don’t have to follow the people in this study for 10 years to see what will happen. Our goal is to gain the knowledge that if we reduce these risk factors, the incidence of diabetes will be reduced.”