Diabetes research failing to address prevention

Laura Dobberstein

The prevention of diabetes is being overlooked by diabetes researchers, according to a recent study. “Our descriptive analysis found that the majority of registered [diabetes] trials involve drug therapies rather than preventative or non-drug interventions,” said study author Dr. Jennifer Green of Duke University Medical Center in Durham, North Carolina, US, and colleagues. Green and her team examined 2,484 interventional diabetes trials registered on the ClinicalTrials.gov website between 2007 and 2010, to better understand which aspects of the disease were being addressed. [Diabetologia 2013; doi:10.1007/s00125-013-2890-4] While 75 percent of the trials had a primarily therapeutic purpose, only 10 percent focused on prevention. Sixty-three percent of interventions used drugs and only 12 percent looked at modifiable behaviors. Their findings also indicated some important demographic disparities of trials, which tended to exclude children and the elderly, were often small in size and duration, did not geographically represent populations of those living with diabetes, and did not focus on significant cardiovascular outcomes like heart attack and stroke. Twenty percent of adults over age 65 have diabetes, but less than 1 percent of the trials included patients in this age group. Most trials excluded patients over 75 years of age and 30.8 percent excluded those over the age of 65. Four percent of trials targeted those under the age of 18. This low number of pediatric trials may accurately reflect the proportion of people in this age group affected by diabetes. However, arguments exist as to why this group should be better represented in research. A 3 percent annual increase in type 1 diabetes currently exists among those under the age of 18. In addition, children have a higher chance of developing complications during their disease course and benefit more from better disease management than their older counterparts. The small size and duration of the trials concerned the researchers. The average length of a trial was less than 2 years. Over half of all trials had fewer than 100 participants and 91 percent had fewer than 500 participants. Complications like diabetic retinopathy, lower extremity amputation and end-stage renal disease vary among ethnic groups, making it important to include a diverse background of people in diabetes research. Study populations were overrepresented by patients from North America, Western Europe and certain Asian countries, but underrepresented by patients from other important regions such as Russia, Brazil and the Middle East. Cardiovascular complications related to diabetes have become an important research topic, particularly in relation to medication development. Yet mortality and cardiovascular complications were only reported in 1.4 percent of trials. The researchers concluded that current clinical trials on diabetes research do not adequately address disease prevention, management or therapeutic safety. The results from this study build a better understanding of ongoing research and could help direct future research activities and resources. source: CIMS India (MedicalTribune)