The Look AHEAD (Action for Health in Diabetes) Study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), began in 2001 to examine whether weight loss and increased physical activity would prevent cardiovascular events in those with type 2 diabetes. The study, which produced several positive results, continues today in an observational phase.
Karen C. Johnson, MD, MPH, professor and interim chair of the Department of Preventive Medicine at the University of Tennessee Health Science Center (UTHSC), one of 16 study centers for Look AHEAD, was recently awarded $1.6 million from the NIDDK to fund the observational phase of the study here through 2015.
The clinical trial, which enrolled more than 5,000 people nationally, showed that weight loss and increased physical activity improved many cardiovascular risk factors for those with diabetes, including blood pressure, blood sugar and cholesterol, and had other benefits, including reduced depression, better sleep and improved memory.
However, the NIDDK, a division of the National Institutes of Health (NIH), stopped the clinical trial in late 2012, when evidence did not show that the changes prevent cardiovascular events. NIDDK continues to fund the study in an observational phase through 2015, to follow long-term effects of the weight loss and physical activity on the health of participants.
During the clinical trial, participants were divided into two groups. One group received intensive lifestyle intervention, including individual supervision, group sessions and diet strategies. The other received more limited diabetes support and education. Since the intensive intervention aspect of the study is over, participants will come to UTHSC once a year for measurements, blood samples, an EKG, and tests for physical and mental function.
“We’re assessing physical function and cognition in the observational phase, because we believe that weight loss and physical activity may improve your physical function and may improve your cognitive ability,” Dr. Johnson said. The UTHSC study includes slightly more than 300 people. “The data from the trial period does appear like the intervention group may have reduced total mortality, but it’s not statistically significant yet, so we’re continuing to follow the individuals for that as well.”
Dr. Johnson and co-investigator, Helmut Steinberg, MD, professor of endocrinology at UTHSC, hope to extend this observational phase through 2020.
“We know the Look AHEAD intervention lowered blood sugar, we know it lowered cholesterol, we know it lowered blood pressure, and all of these changes may ultimately reduce heart disease,” Dr. Johnson said. “That’s why we think if we follow the Look AHEAD participants long enough, we may begin to see some legacy effects.”
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), approximately the fifth largest Institute at the National Institutes of Health, conducts, supports, and coordinates research on many of the most serious diseases affecting public health.
The National Institutes of Health (NIH), the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.