Study: More than 80% of patients with diabetes risk factors missed by traditional testing - Applied Clinical Trials


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Study: More than 80% of patients with diabetes risk factors missed by traditional testing HDL, Inc. researchers show clinical utility of comprehensive biomarker testing in diabetes prevention

Study: More than 80% of patients with diabetes risk factors missed by traditional testing

HDL, Inc. researchers show clinical utility of comprehensive biomarker testing in diabetes prevention

PR Newswire

RICHMOND, Va., Aug. 7, 2014 /PRNewswire/ -- Comprehensive biomarker testing of insulin resistance and pancreatic beta-cell dysfunction identifies diabetes risk earlier than current glycemia-based approaches, according to a new peer-reviewed study published online in the Journal of Cardiovascular Translational Research.

HDL, Inc. researchers have shown clinical utility of comprehensive biomarker testing in diabetes prevention in a new
               peer-reviewed study. The researchers uncovered more than 80% of patients with diabetes risk factors that were missed by traditional

The study from researchers at Health Diagnostic Laboratory, Inc. assessed 1,687 patients at risk for cardiovascular disease under routine clinical care with a comprehensive panel of biomarkers related to insulin resistance (IR), beta-cell function, and glycemic control. On the basis of traditional fasting glucose and HbA1c levels, 415 patients (25%) had glycemic indicators consistent with prediabetes and 343 (20%) with diabetes, reflecting a high-risk cohort.

However, 766 patients that were not classified "at risk" of developing diabetes by traditional measures were identified with one or more biomarkers of IR or beta-cell dysfunction. After five months of treatment and lifestyle intervention, the proportion of patients who improved their glycemic status was significantly greater than those who worsened (35% vs. 9%; P<0.0001). For those patients in the "high-normal" category of HbA1c values (5.5-5.6), 56% of patients improved glycemic status, while only 18% worsened (P<0.0001).

"This study shows that comprehensive, multimarker testing can identify IR early, enable and inform treatment, and support improvements in glycemic control in a high proportion of patients. The ability to detect risk for progression to diabetes earlier than is currently possible with the tools available to most clinicians is of critical importance in the effort to address the growing diabetes epidemic," said Szilard Voros, M.D., a study author and HDL, Inc. Chief Clinical Strategy Officer. "The findings represent a substantial increase in sensitivity of diabetes risk detection, and earlier detection allows appropriate interventions to be administered when they are likely to be most effective. Preservation of pancreatic beta-cell function has been shown to be the key to achieving positive clinical outcomes."

Diabetes has reached epidemic proportions, affecting more than 366 million people worldwide and more than 25 million in the U.S. If trends continue, 1 in 3 Americans will meet criteria for diabetes by 2030. Prediabetes affects more than 87 million U.S. adults and confers a lifetime risk of conversion to diabetes of 30-50%. Insulin resistance syndromes (diabetes, prediabetes, and metabolic syndrome) are associated with up to 70% of cardiovascular disease (CVD) cases, and adults with diabetes are twice as likely to die from heart disease and stroke than those without. The American Diabetes Association estimates the cost of managing diabetes for one year to average $7,900 per patient, and if current trends continue, type 2 diabetes is projected to cost the U.S. $500 billion per year by 2020.

The study from HDL, Inc. shows three main findings:

  • Physiological signs of IR and beta-cell dysfunction were identified in 80% of at-risk individuals who would have been classified as 'normoglycemic' by conventional glycemic criteria;
  • No single biomarker was responsible for the increased sensitivity; diverse patterns of biomarker abnormalities were observed, particularly in the patients with normal glycemic markers; and,
  • The improvements in glycemic category observed in the subset of patients for which follow-up data was available suggest that this multimarker approach can be successfully implemented in routine clinical practice to improve traditional goal attainment and, potentially, patient outcomes.

"The study clearly demonstrates that a large number of individuals with 'normal' glucose and HbA1c values actually have early-stage metabolic disease," said Stephen Varvel, Ph.D., the study's lead author and HDL, Inc. Director of Clinical Trials. "Although this hypothesis will need to be tested in large, randomized, prospective clinical studies, using a comprehensive biomarker panel to identify these at-risk individuals will allow prompt intervention that may reverse the disease course and prevent progression to diabetes."

To read and download the study, "Comprehensive biomarker testing of glycemia, insulin resistance, and beta cell function has greater sensitivity to detect diabetes risk than fasting glucose and HbA1c, and is associated with improved glycemic control in clinical practice" in the Journal of Cardiovascular Translational Research, click here.

About Health Diagnostic Laboratory, Inc.
Founded in 2008, Health Diagnostic Laboratory, Inc. (HDL, Inc.) is a leader in health management offering a comprehensive test menu of biomarkers that uncover risk for cardiovascular disease, diabetes, and related diseases. HDL, Inc.'s systematic approach identifies specific factors contributing to disease and provides a basis for more targeted treatment, allowing physicians to more effectively manage their patients and individuals to take steps to improve their health. Individuals receive a personalized overview of their risk factors along with intensive counseling from expert Clinical Health Consultants. This tailored health coaching, generally provided at no additional cost, helps improve compliance and enhance satisfaction. Through the My Health Counts program, HDL, Inc. delivers comprehensive testing and wellness services to populations, including employers and value-based, integrated care models such as Accountable Care Organizations (ACOs), and health systems. HDL, Inc. is a CLIA-certified, CAP-accredited laboratory. For more information, visit, and make HDL, Inc. part of your digital lifestyle at and on Twitter @hdltweets.

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SOURCE Health Diagnostic Laboratory, Inc.


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