Pilot study to evaluate freezing procedure for patients with Type 2 diabetes
A study is underway at Emory Johns Creek Hospital (EJCH) to assess the feasibility of cryoablation, or the use of extreme cold for patients with Type 2 diabetes.
The one-year pilot study, called "Percutaneous CT-guided cryoablation of the splanchnic nerves for the management of Type 2 diabetes" will enroll five patients between the ages of 22 and 65 at EJCH. The splanchnic nerves are located on both sides of the spine. The nerves carry both visceral sympathetic and sensory fibers.
According to the Centers for Disease Control and Prevention (CDC), 34.2 million people in the United States are living with diabetes, and approximately 90 to 95 percent have Type 2 diabetes, the most common form of the disease.
J. David Prologo, MD, director of Interventional Radiology Services at EJCH, and associate professor in the Department of Radiology and Imaging Sciences in Emory's School of Medicine is the principal investigator for the new FDA-regulated study at Emory.
"We use CT-image guidance to pinpoint the splanchnic nerves, freeze them and hopefully decrease blood sugar in patients with insulin resistance," says Prologo.
Researchers will evaluate patients at baseline, day seven, 30, 180, and 360 post-procedure.
"Our team will examine a plethora of data including glycemic control, body weight, lipids, systolic, diastolic and orthostatic blood pressure measurements, among other things throughout the study and track the changes compared to baseline after the procedure," says Prologo.
An Emory Healthcare registered dietitian and exercise physiologist will provide standardized diet and exercise counseling to all subjects at no cost.
The study is funded by the Georgia Research Alliance and The Emory Synergy Grant Mechanism. Eligible candidates will have a hemoglobin A1C value from 7.5 to 10.5 percent, a BMI of 30 to 37, and a diagnosis of Type 2 Diabetes for less than 10 years.
Participation in the study is voluntary. For more information about this clinical trial, contact the study coordinator, Zohyra Zabala, at zohyra.zabala@emory.edu.
