Newswise — WASHINGTON – Researchers have developed a new test that could diagnose chronic kidney disease early in patients with type 2 diabetes. This novel method, published today in AACC’s Clinical Chemistry journal, could improve quality of life for diabetic patients by potentially catching chronic kidney disease in time to stop its progression to full-blown kidney failure. 

More than 35% of diabetic patients aged 20 years or older have chronic kidney disease, a condition in which the patient gradually loses kidney function. If left unchecked, this disease can progress to end-stage kidney failure, which is fatal unless the patient is able to get regular dialysis or a kidney transplant, and chronic kidney disease also increases the risk of other serious chronic conditions such as cardiovascular disease. With diabetes becoming a global epidemic, it is more important than ever for healthcare providers to detect chronic kidney disease early so that patients can undergo timely interventions that slow the progression of this condition. However, the tests currently used to gauge the severity of kidney damage in diabetics do not reliably detect chronic kidney disease in its initial stages.  

In a new study, a team of researchers led by Guillaume Paré, MD, of McMaster University in Hamilton, Ontario, shows that a test for the protein trefoil factor 3 (TFF3) could meet the need for an early chronic kidney disease diagnostic. To develop this test, Paré’s team first analyzed data from more than 130,000 participants in various chronic kidney disease studies to identify genetic variants that are linked with declining kidney function. Using an innovative analysis method known as reverse Mendelian randomization, the researchers then determined if these genetic variants are associated with any biomarkers that were measured in more than 4,100 type 2 diabetes and prediabetes patients who participated in the 2003-2005 ORIGIN study. Finally, Paré’s team assessed whether the biomarkers identified by reverse Mendelian randomization predicted the eventual development of chronic kidney disease in the ORIGIN participants, who had normal kidney function at the study’s start. 

Through these analyses, the researchers found that when kidney function decreases, TFF3 is the one biomarker that is directly affected, i.e. its levels increase in response. Furthermore, Paré’s team demonstrated that 34.4% of diabetic patients in the highest quartile of blood TFF3 levels went on to develop chronic kidney disease, compared with only 19.8% of patients in the lowest quartile. This shows that individuals with high levels of TFF3 have a significantly greater risk of developing chronic kidney disease and indicates that diabetic patients with elevated TFF3 results could potentially benefit the most from early chronic kidney disease interventions. 

“We demonstrated TFF3 concentration is a significant independent predictor of incident chronic kidney disease in a dysglycemic population,” said Paré. “Future research should be directed toward better elucidating the biological role of TFF3 and trefoil family proteins in the kidneys and further evaluating the clinical utility of TFF3 as an early diagnostic tool for chronic kidney disease in broader populations. Importantly … reverse [Mendelian randomization] could be a novel method used to identify sensitive and early diagnostic biomarkers for a variety of other diseases.”

About AACC

Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit

Clinical Chemistry is the leading international journal of clinical laboratory science, providing 2,000 pages per year of peer-reviewed papers that advance the science of the field. With an impact factor of 8.636, Clinical Chemistry covers everything from molecular diagnostics to laboratory management.


Journal Link: Clinical Chemistry, Oct-2018