Statement of Griffin P. Rodgers, M.D., Director, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, on World Diabetes Day

Source: NIDDK
Date: Nov 14, 2007


Patient Participation in Clinical Studies Is Critical for Progress

As nations across the globe observe World Diabetes Day, we at the National Institutes of Health (NIH) reaffirm our commitment to leverage the best minds and tools of science to improve the prevention, diagnosis, and treatment of diabetes, with the goal of finding cures for this debilitating group of diseases.

This is a time of excitement and anticipation in the diabetes research community. What we’ve learned in just the past decade has transformed the way diabetes is prevented and treated, and we look forward to many new findings as the pace of discovery accelerates. Ten years ago, for example, we did not know that type 2 diabetes could be prevented or delayed in high-risk people. We did not know that an individual’s risk for developing type 1 diabetes could be accurately predicted. Nor did we know many of the gene variants that predispose individuals to type 1 or type 2 diabetes. These discoveries and many others have laid the groundwork for current research and future solutions to the challenges of diabetes.

Reflecting on these milestones, we’re reminded of the enormous contribution that patients and those at risk for diabetes have made in the quest for answers. To the thousands of individuals who participated in, and continue to participate in, clinical trials such as the Diabetes Control and Complications Trial, the Diabetes Prevention Program, and other studies, we owe a tremendous debt of gratitude. Patients are critical members of the research team. What they’ve taught us has fundamentally changed medical practice and helped move advances to the bedside. These trials are still providing valuable insights that are informing efforts to prevent and treat diabetes.

This year, World Diabetes Day focuses on diabetes in children and adolescents. The NIH funds a number of clinical studies to understand, prevent, and treat diabetes in young people, who are increasingly developing both type 1 and type 2 diabetes. I’d like to highlight a few of these studies, which are described in detail in www.clinicaltrials.gov:

Type 1 diabetes
Arising from a combination of genetic and environmental factors, type 1 diabetes is an autoimmune disease in which a person’s own immune cells destroy the insulin-producing beta cells of the pancreas. From earlier studies, scientists have learned that, in genetically susceptible people, blood levels of specific autoantibodies accurately predict the risk of developing type 1 diabetes in the next five years.

• A research network called Type 1 Diabetes TrialNet is applying this and many other scientific advances in its trials to prevent or delay diabetes. The studies are enrolling blood relatives, including children, of people with type 1 diabetes.
• Intensive blood glucose control prevents the complications of type 1 diabetes, and a functioning supply of insulin-producing beta cells makes it easier to control glucose. TrialNet researchers are collaborating with the Immune Tolerance Network, also funded by the NIH, on studies to protect the beta cells of people recently diagnosed with type 1 diabetes. This work is under way in medical centers across the United States, Canada, Europe, and Australia.
• The international Type 1 Diabetes Genetics Consortium is working to find all the genes that raise or lower a person’s risk for developing type 1 diabetes. Many such genes have already been identified, so researchers are widening their search to look for gene variants that confer protection or susceptibility to type 1 diabetes in populations where the disease is less common.
• Another priority is to identify the environmental factors that contribute to type 1 diabetes. The TEDDY (The Environmental Determinants of Diabetes in the Young) study is looking for the infectious, dietary, or other environmental factors that trigger type 1 diabetes in those who are genetically at risk. TEDDY is enrolling newborns who are first-degree relatives of individuals with type 1 diabetes. The researchers plan to follow the children for 15 years while tracking diets, infections, vaccinations, and other factors as well as the appearance of autoantibodies and the possible development of diabetes.
• The Diabetes Research in Children Network (DirecNet) is expanding the understanding of hypoglycemia in children with type 1 diabetes and is researching ways to prevent it. The network is currently studying the safety and efficacy of devices that continuously monitor blood glucose levels in children. DirecNet’s ultimate goal is to “close the loop” between technologies that precisely deliver insulin in response to automatically measured blood glucose levels.

Type 2 diabetes
Type 2 diabetes, which also arises from a combination of genetic and environmental factors, is by far the most common form of diabetes. It is closely linked to obesity, physical inactivity, a family history of the disease, and it disproportionately affects minorities. Earlier this year, three research teams announced the results of powerful genome-wide association studies, which confirmed six gene variants and identified four new gene variants that confer susceptibility to type 2 diabetes. Understanding the function of these genes should open new pathways to prevention and therapy.

Once rarely seen in children, type 2 diabetes is increasingly being found in youth. This is a troubling development because complications such as heart disease are likely to appear earlier, stealing more years of healthy life. The NIH is funding two major studies to find the best way to prevent and treat type 2 diabetes in youth:

• The Healthy Study will determine whether a school-based program that provides a healthier diet and increased physical activity can prevent the risk factors for type 2 diabetes in middle-school children. This study is taking place in 42 middle schools nationwide.
• The TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) Study is comparing three approaches to the treatment of youngsters with type 2 diabetes diagnosed in the previous 2 years. This three-arm study includes an assessment of metformin therapy combined with an intensive program to improve diet and increase activity.

Finally, we are developing methods to achieve in practice what research has already shown to be important. We know, for example, that control of blood sugar, blood pressure, and cholesterol reduces complications, but many people are not achieving the recommended goals. With translational research, we are looking for ways to make diabetes treatment simpler and to help people manage their diabetes more easily.

In Fiscal Year 2007, the NIH dedicated about $1 billion to fund a diabetes research program that addresses urgent scientific questions. The gravity of the diabetes epidemic reinforces our determination to continue funding a rigorous research agenda that exploits the most promising scientific opportunities and moves promising findings to patients and those at risk as quickly as possible.

Dr. Rodgers is director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health in Bethesda, Maryland.

Media inquiries can be directed to the NIDDK Office of Communications and Public Liaison at 301-496-3583, Niddkmedia@mail.nih.gov.

The NIDDK, a component of the NIH, conducts and supports research in diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe, and disabling conditions affecting Americans. For more information about NIDDK and its programs, see www.niddk.nih.gov.