Читать книгу The SAGE Encyclopedia of Stem Cell Research - Группа авторов - Страница 388
Government Steps in the Implementation of Clinical Trials: Perspective
ОглавлениеDiabetes is a lifelong condition and the number of children being diagnosed with type 1 diabetes is constantly growing. Although the symptoms can today be controlled, there is no cure. For many people, diabetes signifies long-term health issues and daily injections of insulin. How might clinical trials help? How might stem cells benefit patients? The landscape of novel therapies to advance treatment for people with diabetes is evolving.
Judith Fradkin, director of the Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), discussed, not long ago, the NIDDK’s research initiatives of setting up and implementing clinical trials for diabetes that would be sponsored by the government and that are “not currently pursued by drug companies.”
One of the successes of the National Institutes of Health (NIH)/NIDDK multicenter trials pointed to by Fradkin, is the success in recruiting ethnically heterogeneous populations. The government-sponsored initiative includes about 45 percent of minority groups. The study looked at the incidence rates of diabetes based on three factors: the use of metformin, the presence of a placebo, and lifestyle intervention. The benefits of metformin and lifestyle interventions in the reduction of the incidence of type 2 diabetes were clear across all of the ethnic groups under study. This fact alone proved to be key, as it indicates that type 2 diabetes affects minority populations in a disproportionate manner compared to other racial groups.
An additional positive outcome that resulted from this study has been that, in addition to the inclusion of diverse ethnic groups, trials sponsored by the government have succeeded in classifying diabetic patients by phenotype. Such an unexpected finding has had important impact on the development of type 1 diabetes trials. The study also succeeded in creating some phenotyping following pharmacogenomics analyses. The results revealed that even for people with higher genetic risk for type 2 diabetes, lifestyle interventions may succeed in reducing their level of risk. This was described by the community of scientists as “a powerful result” indicating that genetics is far from being synonymous with destiny when it comes to developing type 2 diabetes.