New Prognostic Test May Improve Clinical Trial Study Design for Types 1 and 2 Diabetes Patients

New Prognostic Test May Improve Clinical Trial Study Design for Types 1 and 2 Diabetes Patients

Researchers at Boston’s Joslin Diabetes Center have developed a prognostic tool that predicts the risk of end-stage renal disease (ESRD) in patients with type 1 or type 2 diabetes.

“Overall efficiency and cost effectiveness of clinical trials depends on the diagnostic tools used to enroll study patients,” Andrzej S. Krolewski, MD., Ph.D., head of genetics and epidemiology at the center, said in a press release. “If you recruit people who are not at risk of progressing to ESRD during the clinical trial period, statistical power declines and you can’t prove anything.”

These findings appeared online in Kidney International, under the study, “Improved clinical trial enrollment criterion to identify patients with diabetes at risk of end-stage renal disease.”

Clinical identification and trial selection of patients at risk for developing ESRD has usually included assessment of two specific biomarkers: urinary albumin to creatinine ratio (ACR) and estimated glomerular filtration rate. However, many researchers suggest that using only these biomarkers not only misses many patients at high risk for renal failure but also fails to accurately predict the onset of ESRD.

Past research by Krolewski and his team showed a correlation between tumor necrosis factor receptor 1 (TNFR1) and declining renal function in both type 1 and type 2 diabetes. In the current study, Krolewski’s team developed a practical tool that’s readily available to physicians to improve treatment-making decisions as well as more easily enroll patients in clinical trials.

The current study involved patients with both diabetes and stage 3 and 4 chronic kidney disease. Researchers followed these patients for four to 15 years to monitor the development and onset of ESRD. Their results show that specific values of two biomarkers — circulating level of TNFR1 and ACR combined — indicate high risk of ESRD. They also found that this prognostic test is accurate for both type 1 and type 2 diabetes.

“This is a very important observation because in the medical community, the impression is that the progression to ESRD in type 1 is somehow different from type 2,” said Krolewski. “As a result, many clinical trials do not include patients with type 1.”

Not only does this discovery change the way patients can be enrolled in clinical trials — hopefully decreasing the number of patients needed to maintain statistical power to prove results — but they also suggest the TNF receptor as a potential therapeutic target.

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