Clinical trial to study effects of Chromium picolinate supplementation initiated
To study the effects in overweight pediatric patients with poorly-controlled type 1 diabetes.
16/02/05 Nutrition 21, Inc. has announced 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.
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.
Chromium is an essential trace mineral critical to proper insulin function and necessary for carbohydrate, fat and protein metabolism.
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(R) chromium picolinate, which is the most-studied form of the essential mineral chromium. Nutrition 21 also developed Diachrome(R), 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.