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Archive - Meet the ResearcherDr. Lawrence Lavery, DPM, MPH – Scott and White Hospital Sangita Sharma, PhD – University of Hawaii Valerie Duffy, PhD, RD – University of Connecticut Victor Montori, MD, MSc – Knowledge and Encounter Research Unit, Mayo Clinic Dr. Lawrence Lavery, DPM, MPH – Scott and White HospitalDiabetes complications are one of the many research areas funded by the American Diabetes Association. In a joint effort, the American Diabetes Association and the American Podiatric Medical Association (APMA) are sponsoring a fellowship to provide an opportunity for a podiatrist to get postdoctoral training in a diabetes research lab. According to the ADA, about 60% to 70% of people with diabetes have mild to severe forms of nervous system damage. The results of such damage include impaired sensation or pain in the feet or hands. Almost 30% of people with diabetes aged 40 years or older have impaired sensation in the feet (i.e., at least one area that lacks feeling). With such a high incidence of nerve damage and sensory issues, a strong case is made for directing research efforts to these complications. 
Meet Dr. Lawrence Lavery, DPM, MPH of the Scott and White Hospital in Temple, Texas. He is the recipient of the ADA-APMA Mentor-based Postdoctoral Fellowship award which began in July 2007. Dr. Nathan Hunt, DPM, the postdoctoral fellow training with Dr. Lavery, will learn to conduct clinical research and enhance the understanding of diabetic foot research and complications. To engage in his training, Dr. Hunt's first task is to work on Dr. Lavery's ADA Clinical Research Award entitled, "Epidemiology of Lower Extremity Complications in Dialysis Patients with Diabetes." Evaluating the occurrence and frequency of lower extremity complications in persons with diabetes and on dialysis is the first of three objectives in this ADA project. Complications could include blocked arteries in the arms and legs (peripheral vascular disease), sensory nerve damage (sensory neuropathy), chronic damage to the foot and ankle joint bones (Charcot fractures), wounds, amputations, infections and even death. The research team expects that there will be a higher occurrence and frequency of lower extremity complications in persons who receive dialysis treatment. They will perform an analysis of 337 patients for two years to answer this question. Identifying the risk factors and causal pathways for lower extremity complications in those receiving dialysis is the main focus of the secondary objective. Comparing and evaluating patient s with and without lower extremity complications will provide answers as to whether there is a unique set of risks to those who receive dialysis. Here, they will follow and analyze data from patients during a two year period as well. Finally, the last objective is to evaluate the health-related quality of life for dialysis patients with or without lower extremity complications. Not only do researchers hypothesize that the quality of life will be worse in those with foot complications but they also believe that there will be lower values in patients who undergo dialysis as compared to those who do not undergo dialysis. This expectation is based on previously observed patients that participated in clinical research studies. The future of diabetes research will be enriched with the ADA-APMA fellowship and the outcomes of the ADA study. With Dr. Hunt's mentored training, the diabetes complications research field will benefit from a specialized investigator. Trained investigators increase research, discoveries and prevention of diabetes complications. Dr. Lavery states, "Advances in medicine are often driven by new clinical investigators, so training researchers is essential to improve the lives of people with diabetes." Analysis and data reporting performed by Dr. Hunt will provide new information about foot complications in end stage renal disease. Identifying the occurrence, frequency, risk factors and causal pathways of lower extremity complications could lead to improved strategies in prevention and intervention. Sangita Sharma, PhD – University of HawaiiSangita Sharma, PhD is currently conducting research at the University of Hawaii in Honolulu, Hawaii. She is the recipient of an ADA Clinical Research Award for her project entitled, “Intervention for a chronic disease epidemic: community health initiatives and promotion strategies for diabetes prevention (ICE CHIPS) in Native North Americans.” 
American Indians, Alaskan Natives and other native populations in North America are showing signs as a group of succumbing to the diabetes epidemic that affects millions of Americans. Dr. Sharma’s research focuses on diabetes prevention and education in the Native North American (NNA) community. Diabetes research has many focus areas, but Dr. Sharma believes that it should incorporate culturally diverse approaches to prevention as well. She states, “We need to understand the causes of diabetes and the underlying mechanisms, but we also need to research the best approaches for prevention of diabetes in different populations.” Dr. Sharma’s approach to prevention of diabetes in this ethnic population is a comprehensive program named Healthy Foods North. In this program, in-depth community involvement focuses on an individual’s dietary intake and physical activity level. The Healthy Foods North program embraces the American Diabetes Association’s position on the prevention of the risks for diabetes. According to the ADA’s “Standards of Medical Care in Diabetes” published in Diabetes Care (Diabetes Care 2008 31: S61--S78), individuals at high risk for developing type 2 diabetes should participate in structured programs that emphasize lifestyle changes that include moderate weight loss (7% body weight) and regular physical activity (150 min/week), with dietary strategies including reduced calories and reduced intake of dietary fat. These lifestyle changes can reduce the risk for developing diabetes. According to Dr. Sharma’s preliminary research, the NNA population exhibits a sedentary lifestyle, a strong risk factor for development of type 2 diabetes. Preliminary data has already confirmed that this population’s dietary consumption of fewer fruits and vegetables, as well as more high fat, high sugar and processed foods, contributes to the increased incidence of type 2 diabetes in this population. So, in an attempt to prevent type 2 diabetes in the NNA population, she has chosen to apply a lifestyle modification program to participating individuals in her research study. Quantitative information on research participant’s height, weight, amount of physical activity, and diet is collected for comparison pre- and post-intervention. Psychosocial factors that affect health behaviors and food choices are also collected as part of the overall assessment. Administering two newly created quantitative food frequency questionnaires for use by the communities will help determine food and nutrient intake. In addition to the dietary intervention, the research study is incorporating a physical activity component as well. Any community member can collect (from the stores in town or project staff), a pedometer which measures their activity levels. Friendly competition is also used as a motivator, with community walk teams formed to see who walks the most steps. Involving the entire community is the unique factor in Dr. Sharma’s ADA- funded research program. She is engaging the community food stores to collaborate with the program by getting them to stock more healthy foods, providing Healthy Foods North educational materials for them to display as well as performing taste tests and recipe ideas for the customers. Not only is Dr. Sharma’s program going to reinforce community programs aimed at physical activity but she will maintain the longevity of the program by having it integrated into community programs by the local government. The Healthy Foods North program will be advertised and promoted through local community events, health centers and radio and other media. The program researchers have also conducted workshops within the communities to determine the most acceptable, healthier food alternatives. Dr. Sharma states, “My ADA funding means that I can undertake and subsequently evaluate the program to determine if it really works to improve diet and physical activity and reduces risk of diabetes. If the program is as successful as I am confident it will be, then I hope to be able to utilize the approach in other high-risk diabetes populations.” Valerie Duffy, PhD, RD – University of ConnecticutValerie Duffy, PhD, RD, at the University of Connecticut, was the recipient of the ADA-- Healthy Food Choices Research grant funded by the ARAMARK Charitable Fund. Dr. Duffy’s research entitled, “The Captain 5 A Day Program: Improving dietary quality and physical activity in preschoolers" could impact the long--term health goals of children in preventing obesity, a common risk factor for type 2 diabetes.  The Captain 5--A--Day program targeted preschoolers, parents and educators and provided a curriculum that increased vegetable and fruit consumption and encouraged healthy food choices. Teachers provided classroom guidance and incorporated a 16-- week lesson plan in addition to regular classroom instruction. Parental involvement was achieved through child--family activity worksheets, participating in workshops and logging in for web site activities. The program’s impact was evaluated via preschooler’s consumption of vegetables served at lunch. Since teachers eat with preschoolers, their rating of vegetable consumption was evaluated for feasibility and utility as an outcome measure against vegetable consumption assessed by plate waste method. Teachers scored the preschooler’s vegetable as “less than usual," “always a poor vegetable eater," “improved," “always a good vegetable eater," and “more than usual." Improvements in preschooler’s vegetable consumption in the intervention versus control group were shown with both teacher scoring and plate waste, suggesting the former as a useful and less time--intensive way for evaluating the success of the Captain 5 A Day intervention. The student’s Body Mass Index was also calculated. The child’s information was collected and saved for a later comparison at the completion of the program. In its third year, the Captain 5--A--Day program has reached 800 preschoolers with teachers reporting a significant increase in vegetable intake at school lunches. Despite the overall increase in vegetable consumption within the study, there were still some children who had not increased their vegetable intake. Dr. Duffy has identified the bitter taste of the vegetables as one barrier to the preschooler’s consumption. To address this, she treated the vegetables with a light misting of a sweetener--aspartame in pilot testing and sucralose in subsequent testing. Sucralose and Aspartame are common sugar substitutes used in commercial markets and are FDA approved. The ADA accepts that these substitutes are safe and in moderation can be implemented as part of a healthy diet. Masking the bitter taste, Dr. Duffy found that 2 of 3 preschoolers preferred this preparation to the usual cooked vegetable--only preparation. This result parallels her research with adults; 1 of 3 adults likely taste minimal bitterness in vegetables. Balance between the natural sweetness and bitterness results in a greater preference for the vegetables. For the other 2 of 3 individuals, adding minimal sweetness with more pronounced bitterness increases their preference for vegetables (similar to adding a bit of sugar to the water when cooking vegetables). In the next phase of research, the Captain 5–A--Day program will utilize the new method of food preparation as a means of increasing vegetable consumption. The goal of the study is to use the sweetener just to establish preference for the vegetable and then to do a gradual and “stealth" reduction of sweetener to maintain the vegetable preference without the need for sweetener additive. In addition, collaboration with Dr. Susan Mayne of Yale University will provide a new scientific method of quickly assessing fruit and vegetable consumption— resonance Ramen spectroscopy (RRS). RRS is a painless, non--invasive technique that uses light on the skin surface to determine the amount of pigments obtained from the vegetables. In this study, the skin on the palm of the hand is scanned for less than 30 seconds with a blue light. Dr. Duffy’s research serves as a significant step forward in the prevention of type 2 diabetes in children. According to the ADA’s “Nutrition Recommendations and Interventions for Diabetes" published in Diabetes Care (Diabetes Care 2008 31: S61--S78), there is no data that can lend itself to recommendations for children. Research is still ongoing in children’s studies. However, the ADA suggests that adult nutrition recommendations for prevention of type 2 diabetes can be followed by youth and could be just as effective. Current nutritional recommendations from the American Diabetes Association include eating fruits and vegetables, eating whole grain foods, choosing lean meats, drinking water and cutting back on high calorie foods and desserts. According to Dr. Duffy, the research grant provided by the American Diabetes Association has advanced school--based programs that are well--accepted by teachers, parents and administrators and improves the dietary quality of preschoolers. The funding is stimulating new and feasible means of evaluating the impact on school--based initiatives. The funding has also allowed dietetics students to increase their knowledge, skills and competence in community--based health promotion. The future scientists and practitioners who work on this project will take their knowledge with them as they advance in their careers. This research study has encouraged collaboration between field researchers and community partners in health promotion, influenced the future dietary behavior of children and contributed to the advancement of knowledge in children’s dietary research. Victor Montori, MD, MSc – Knowledge and Encounter Research Unit, Mayo ClinicVictor Montori, MD, MSc, was the recipient of an ADA-Novo Nordisk Clinical Research Award to help determine the best way to help people with type 2 diabetes make decisions about diabetes medications, including insulin. This was a competitive grant awarded and administered by the ADA , with funding support from Novo Nordisk, Inc. Dr. Montori explains, “Patients with type 2 diabetes whose pills only achieve limited blood sugar control often delay starting insulin therapy. This delay may increase complications and impair the quality of their lives. Delays may occur because of knowledge gaps, fears, beliefs, and other barriers that disqualify insulin as a valid treatment choice.”
To encourage conversation about medication options, including insulin, between patient and physician, Dr. Montori and his colleagues developed a tool to present unbiased information about different treatment choices, their benefits and drawbacks. In treating type 2 diabetes five of the most commonly prescribed drugs, or classes of drugs, are metformin, sulfonylureas (glipizide, glyburide, glimepiride), thiazolidinediones (brand name Actos or Avandia), exenatide (brand name Byetta), and insulin. To help patients become a part of the medication decision process, Dr. Montori, a group of patients with diabetes from the community, clinicians, and designer Maggie Breslin worked together to develop a decision tool made up of six cards, each detailing an important outcome of using one of the five medications described:
To test the effectiveness of the six “Diabetes Medication Cards,” Dr. Montori’s study team, led by study coordinator Rebecca Mullan, recruited 40 physicians who had patients eligible for the trial. Eligible patients included those who were willing to give informed consent to participate in the trial, had type 2 diabetes for at least one year, had an A1C level between 7-9.5 percent within the last six months, were not on insulin, and were using less than four oral medications to treat high blood glucose associated with their diabetes.
In the experimental group, the physician presented all six cards to the patient at a regular office visit and asked which of the six issues was most important to them personally in deciding which medications to take; this started a conversation that continued with patients reviewing as many cards as they needed to arrive at a decision with their clinician. Dr. Montori and his colleagues then surveyed both groups of patients and physicians after each office visit, and found that, “There was a trend that patients who received the decision aid were more likely to feel that their physician involved them in the decision making process. Most noticeably, 96 percent of patients who received the decision aid strongly agreed or agreed with the statement, ‘My provider identified blood sugar control as a choice that I could participate in,’ compared to 84 percent of patients in the control group.” Dr. Montori reports that weight change was one of the most common concerns among patients in the experimental group, with the weight change card being the card most likely to be chosen first among medication concerns (39 percent), and the second most commonly viewed card (56 percent). The patients who received the decision tool also were more likely to implement a follow-up plan for their next office visit if their A1C did not improve. Finally, insulin as a medication option was discussed in all of the visits in the experimental group. Almost all patients using the cards (96 percent) considered clinicians knew their concerns and preferences regarding diabetes medications compared to 71 percent of patients in the usual care arm. Overall, physicians felt the tool was beneficial. Eighty-four percent of the 21 physicians who used the tool felt that it was helpful in fostering a discussion about medications with their patient, and 90 percent said they would use the cards again. The result of the study was that both the patients and physicians found the cards helpful. According to Dr. Montori, “Compared to usual visits, patients and clinicians using the decision aid were more likely to discuss and consider issues that mattered to patients (such as the effect of medications on their weight). Consequently, patients using the decision aid felt they had greater participation in this decision and that their clinician considered their preferences in making recommendations.” Over the next few months, Dr. Montori and his colleagues will be completing follow-up analysis of their study to determine if patients adhered to their medication decisions and how these cards affected diabetes control. At this time, Dr. Montori and his team have developed instructional videos on how to use the cards (http://mayoresearch.mayo.edu/mayo/research/ker_unit/decision-aids.cfm), a pamphlet of the decision tool for patients, and a prototype of an on-line version of the tool. He hopes to test the tool in larger, more diverse populations, as well as implement another, similar tool (the Statin Choice decision aid) for Spanish-speaking patients. Also, cards focusing on costs and on lifestyle interventions are in the works. Use our searchable Research Database to familiarize yourself with other currently funded ADA researchers.
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Physicians were randomly assigned to use the “Diabetes Medication Cards” decision tool when discussing medication options (experimental group), or to have their usual discussion on medication options without using the tool (control group). Twenty-one physicians and 48 of their patients participated in the experimental group, and 19 physicians and 37 patients participated in the control group. | Información en español | About Us | Donate Now | Join ADA | Volunteer | Message Boards | Sign up for Enewsletters |
