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“How Can Providers Address the Lack of R01

Studies?”

Robert H. Eckel, M.D.Professor of Medicine

Professor of Physiology and Biophysics

University of Colorado Denver

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First, what do we know about NIH support for

obesity science?

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NIH Research Obesity Task Force

• Established by NIH Director Dr. Elias Zerhouni in April 2003.

• A new effort to accelerate progress in obesity research across the NIH.

• Co-Chaired– Dr. Griffin P. Rogers, Director NIDDK– Dr. Elizabeth G. Nabel, Director NHLBI

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Strategic Plan for NIH Obesity Research

• Prevention and treatment of obesity through lifestyle intervention.

• Prevention and treatment of obesity pharmacologic, surgical, or other medical approaches.

• Breaking the link between obesity and its associated health conditions.

• Cross-cutting topics including health disparities, technology, fostering interdisciplinary teams, investigator training, translational research and educational/outreach efforts.

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NIH Components Represented on the Obesity Task Force National Institute of Diabetes & Digestive & Kidney Diseases

(NIDDK) National Heart, Lung, and Blood Institute (NHLBI)

National Cancer Institute (NCI) National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA) National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Arthritis and Musculoskeletal and Skin

Diseases (NIAMS) National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and

Human Development (NICHD) National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA) National Institute of Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR) National Center for Complementary and Alternative Medicine (NCCAM)

National Center on Minority Health and Health Disparities

(NCMHD)National Center for Research Resources (NCRR)

NIH Division of Nutrition Research Coordination (DNRC) NIH Fogarty International Center (FIC)

Office of Behavioral and Social Sciences Research (OBSSR) Office of Dietary Supplements (ODS)

Office of Disease Prevention (ODP) Office of Research on Women's Health (ORWH)

Center for Scientific Review (CSR)

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Presently, the NIH cannot accurately provide information on the # of R01s that address

obesity science.

This will change once the categorization has been modified –

see http://report.nih.gov/rcdc/

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NIH Obesity-Related Funding

2004 Actual

2005 Actual

2006 Actual

2007 Actual

2008 Est’d

2009 Est’d

$423M $519M $594M $661M $660M $659M

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NIH Obesity Research Funding Opportunities

• Obesity Research Solicitations Currently Accepting Applications– RFAs

• RFA-DK-08-009: Neuroimaging in Obesity Research (R01) RFA-HL-08-013: Translating Basic Behavioral and Social Science Discoveries into Interventions to Reduce Obesity: Centers for Behavioral Intervention Development (U01)RFA-HD-08-023: Innovative Computational and Statistical Methodologies for the Design and Analysis of Multilevel Studies on Childhood Obesity (R01)RFA-DK-08-505: Limited Competition: Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) (U01)

– PAs• n = 46

• Ongoing Clinical Trials (Federal and Private) - ClinicalTrials.gov

• n = 1328

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A major question is – do we know that weight loss

prolongs life?

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And the only data come from one study of bariatric

surgery!

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Effects of Bariatric Surgery on Weight in Swedish Obese Subjects

Sjostrom LA et al NEJM 357:471, 2007

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Effects of Bariatric Surgery on Mortality in Swedish Obese Subjects

Sjostrom LA et al NEJM 357:471, 2007

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Will Look AHEAD Answer All the Questions?

• Primary Objective: Assess long-term (11.5 yr) effects of an intensive weight loss

program over 4 years in overweight and obese subjects with type 2 diabetes.– n ~ 5000 men and women– age: 45-74 yr – BMI > 25 kg/m2– Primary outcome – time to a major CVD event– Secondary outcomes – many including all cause

mortality

Controlled Clin Trials 24:610, 2003

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Mean Change from Baseline

P valueIntensive Lifestyle

Diabetes Support/

Education

Weight Loss (%) 8.6% 0.7% <0.001

Waist Circumference (cm)

–6.2 –0.5 <0.001

TG (mg/dL) –30.3 –14.6 <0.001

HDL-C (mg/dL) 3.4 1.4 <0.001

Systolic BP (mm Hg) –6.8 –2.8 <0.001

Fasting Plasma Glucose (mg/dL)

–21.5 –7.2 <0.001

Metabolic Syndrome (%) –14.7 –7.1 <0.001

Look AHEAD Research Group. Diabetes Care 30:1374, 2007

Look AHEAD Trial: Improvement in Metabolic Syndrome Components at 1 Year

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Obesity Research Support Related Questions

• What kind of priority should NIH-supported obesity research funding receive?

• How much money is needed?

• If sufficient funding is provided, how much impact will result?

• What is the role of industry?