May 05 2011

Diabetes Research Strategic Plan

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The media continually alerts us to the epidemic of diabetes in the world.  Diabetes is the seventh leading cause of death.  Worldwide in 2007 there were 246 million people diagnosed with diabetes, and an additional 79 million people are at risk of developing diabetes in the near future.  According to the National Institutes of Health (NIH) there are 25.8 million people of all ages, racial and ethnic groups, and socioeconomic status in the United States that have diabetes mellitus.  There is an equal prevalence in men vs. women; however, more men are undiagnosed.  Even more startling is that in America one in three children born in 2000 may develop diabetes, and diabetes lowers life expectancy by as much as 15 years.

The primary source of federal support for diabetes research comes from the NIH and its National Institute of Diabetes and Digestive and Kidney Disease.  In fiscal year 2009 NIH funding for diabetes research was $1.03 billion with an additional $121 million from the American Reinvestment and Recovery Act.  The NIH contributes to and participates in research in all areas and at all levels from basic to clinical to translational research.  Many clinical research networks and clinical trials have been established to help in the translational research.  In the past decade NIH has supported research leading to a better understanding of the causes of diabetes and its molecular pathways.

The NIH just released a research plan (Advances and Emerging Opportunities in Diabetes Research:  A strategic planning report of the diabetes mellitus interagency coordinating committee, February 2011) identifying opportunities for research on diabetes and its complications over the next decade.  The intent of the plan is to act as a catalyst for multiple efforts focusing on all aspects of diabetes from molecular and cellular processes to translating scientific findings into drugs available for patients.

The NIH report defines 10 major areas of research:

  • Genetic basis of Type 1 and Type 2 diabetes and obesity and their complications
  • Type 1 diabetes and autoimmunity
  • The beta cell
  • Type 2 diabetes as a multi-dimensional disease
  • Obesity
  • Bioengineering approaches for the development of an artificial pancreas to improve management of glycemia
  • Clinical research and clinical trials
  • Special needs for special populations
  • Diabetes complications
  • Clinical research to practice:  translational research

Highlights from one area of the clinical research and clinical trials section of the NIH plan follow.  This section identifies opportunities for research on diabetes and its complications over the next decade.  Major challenges identified are: Type 2 — to extend the period of time that individuals at risk of developing Type 2 diabetes are able to keep their blood glucose levels in the normal range, and to translate these findings into affordable options available to as many as possible; Type 1 – development of treatments that reduce inflammation by altering the immune system, and better examination of cardiovascular disease risk.

Preventing Type 2 Diabetes

The major challenge for prevention of Type 2 diabetes is to translate the results from clinical trials into interventions that are cost effective and can be implemented and sustained in public health programs and in clinical care settings.  Additional opportunities for study include interventions in pregnancy and early childhood to reduce or prevent environmental exposures that increase the risk of Type 2 diabetes for the mother and child.  The exposure of the fetus to high glucose in utero leads to an increased risk of obesity, type 2 diabetes, and other metabolic disturbances later in life.

Key Questions cited by the report are:

  1. How can strategies to prevent Type 2 diabetes be effectively translated into practice, especially among high risk populations?
  2. What are the optimal approaches for controlling glucose in women with gestational diabetes, to decrease their risk for subsequent development of Type 2 diabetes, and to improve pregnancy outcomes?
  3. Which approaches to glucose control in pregnant women with diabetes will prevent or reduce the risk of long-term metabolic consequences in the offspring?
  4. Can a better understanding of pathophysiology from research in genetics and environmental risk factors be used to develop more effective prevention programs?

Future Directions highlighted by the report are:

  1. Conduct studies to understand better how to disseminate the results of clinical trials and promote diabetes prevention.
  2. Conduct clinical trials to test treatments to prevent or treat gestational diabetes.
  3. Conduct long-term studies to determine whether achieving good glycemic control in pregnant women with diabetes will prevent long-term metabolic sequelae in the offspring.
  4. Conduct epidemiologic studies to identify and characterize environmental determinants of diabetes over the lifespan.
  5. Conduct studies to improve understanding of the special needs of older patients with diabetes.

Treatment of Diabetes

Key Questions cited by the report are:

  1. Are there approaches to the initial treatment of Type 2 diabetes that will reverse or slow the decline in beta cell function that occurs over time?
  2. What is the optimal timing for diabetes interventions?  Do specific treatments have maximum benefit at different stages of the disease?
  3. What genetic factors or other patient characteristics influence the choice of initial therapy for individuals?
  4. How can adherence to diabetes treatments be improved?

Future Directions cited by the report are:

  1. Conduct studies to preserve endogenous insulin secretion or induce “remissions” of diabetes.
  2. Determine whether preventing or delaying diabetes can also delay or prevent the chronic complications of the disease.
  3. Evaluate the effect of bariatric surgery procedures on obesity, diabetes, and underlying pathophysiology.
  4. Evaluate early effects and duration of action of current antidiabetic drugs for the initial treatment of early Type 2 diabetes.
  5. Identify biomarkers.
  6. Design well-powered, comprehensive clinical trials aimed at individualizing therapy of Type 2 diabetes.
  7. Examine the causes of and means of improving poor adherence to diabetes treatment regimens.
  8. Describe the epidemiology of hypoglycemia.
  9. Determine whether hypoglycemia unawareness can be prevented or reversed.

The report is a valuable resource for those interested in the NIH’s current research priorities and for future directions for diabetes research.

This is a post by Kathy Grako, Ph.D.  Kathy is a Clinical Strategy Scientist in Cato Research‘s San Diego, CA office.