Former American Diabetes Association President, Francine R. Kaufman, M.D. Leads Investigation at the Childrens Hospital Los Angeles
Los Angeles, CA., February 15, 2005 – Nutrition 21, Inc. (NASDAQ: NXXI) announced today that the Childrens Hospital Los Angeles will conduct the first double-blind, randomized, placebo-controlled clinical trial to study the effects of chromium picolinate supplementation in overweight pediatric patients with poorly-controlled type 1 diabetes. Francine R. Kaufman, MD, director of the Hospital’s Comprehensive Childhood Diabetes Center, is the principal investigator in the seven-month study, to determine if adding 600 mcg of chromium as chromium picolinate to the daily diet of patients 12 to 18 years of age will improve blood glucose and body weight. It is estimated that one in 400 children, or 5 to 10% of the 13 million Americans diagnosed with diabetes, have type 1 diabetes, also known as juvenile diabetes.1
Thirty (30) study participants include female and male patients between the ages of 12 to 18 years with type 1 diabetes for more than one year with a glycosolated hemoglobin (HbA1c) of 7.0% or greater within the last three months and a body mass index (BMI) greater than the 85th percentile for age and gender. The primary outcome measure is HbA1c levels, which measures long-term glycemic control. Secondary outcome measures include blood glucose levels, body weight and BMI, along with cardiac risk factors including lipid profiles, enzymes and blood pressure.
More than 15 scientific studies support the safety and role of chromium in improving insulin function and glucose metabolism in people with type 2 diabetes and related conditions.2 “There is strong scientific evidence to suggest that supplemental chromium picolinate may improve insulin sensitivity, blood glucose control, and cardiovascular risk factors in adults with type 2 diabetes,” according to Dr. Kaufman, former president of the American Diabetes Association and specialist in pediatric endocrinology. “It is of great interest to us to see if chromium picolinate will help young people better manage their diabetes to maximize their long-term health and quality of life.”
Chromium is an essential trace mineral critical to proper insulin function and necessary for carbohydrate, fat and protein metabolism. “We are very pleased to work with Dr. Kaufman on determining chromium’s role in helping treat children with type 1 diabetes,” said James Komorowski, MS, vice president of technical services and scientific affairs, Nutrition 21, Inc., which supplied Chromax® chromium picolinate for the clinical trial. “Chromium picolinate is gaining acceptance among the medical community as a simple, affordable and well-tolerated adjunct nutritional therapy for people with diabetes. This study is important because of the growing need for a safe and effective method of treating insulin resistance in children with and at risk for diabetes.”
People with type 1 diabetes have twice the normal risk for death as people without diabetes and must take insulin in order for their bodies to metabolize sugar into energy.3 Peak incidence occurs around 10 to 12 years of age in girls and 12 to 14 years of age in boys. In addition, according to the American Diabetes Association, type 1 diabetes has shown to shorten the life span of an individual by 12 – 16 years.
About Nutrition 21, Inc.
Nutrition 21 is a nutritional bioscience company and the maker of chromium-based supplements with health benefits substantiated by clinical research. The company markets Chromax® chromium picolinate, which is the most-studied form of the essential mineral chromium. Nutrition 21 also developed Diachrome®, which is available through diabetes educators or at www.diachrome.com. Nutrition 21 holds 36 patents for nutrition products, 27 of which are for chromium compounds and their uses. More information is available at www.nutrition21.com.
Visit www.childrenshospitalla.org for more information on Childrens Hospital Los Angeles.
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1National Institute of Diabetes and Digestive and Kidney Diseases. National Diabetes Statistics fact sheet: general information and national estimates on diabetes in the United States, 2003. Rev. ed. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, 2004.
2Cefalu WT, Hu FB. Role of chromium in human health and in diabetes. Diabetes Care 2004; 27(11):2741-2751.
3Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2002. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2003.
Stacey Antine, MS, RD,