Adult patients needed for UAB clinical trial
UAB researchers have found a way to reverse type 1 diabetes in animal models. Now they need adults aged 19 to 45 years diagnosed with type 1 diabetes to participate in the clinical trial. “They must have been diagnosed within three months of starting the trial with us,” says Anath Shalev, MD, director of the UAB Comprehensive Diabetes Center and principal investigator of the trial.
12 people have joined the trial since January. UAB needs 40 more. “We have continuous recruitment but because of the three-month diagnosis window, it’s a challenge to find suitable participants,” Shalev says.
The biggest surprise with the trial so far has been the numerous misdiagnoses of adults with type 2 diabetes who actually suffer from type 1. “In the old days, type 1 was called juvenile diabetes, so there’s still this misconception that type 1 only affects kids or young people, and that’s not true,” Shalev says.
Around 50 percent of the adults the clinicians have seen were initially misdiagnosed as type 2. “I knew that happened from time to time, but I didn’t know it happened so frequently,” Shalev says.
Shalev actively encourages physicians to send newly diagnosed adult patients who fit the trial’s parameters to the Center for further testing. “We do the testing anyway as part of the screening, so now their patients can know for sure,” she says.
As part of the clinical trial, participants will also receive an insulin pump and a continuous glucose monitoring system. “These devices can get expensive,” Shalev says, adding that physicians should not be concerned about losing their patients to the Center. “We depend on the physician to continue the ongoing care of the participants.”
The clinical trial is testing the efficacy of the common blood pressure drug verapamil to lower TXNIP levels in the beta cells of the pancreas. High blood sugar causes the body to overproduce the TXNIP protein which kills off the beta cells that control blood sugar by producing insulin.
UAB scientists discovered that verapamil, which is also prescribed for migraines and irregular heartbeat, can lower TXNIP in beta cells to the point where diabetes no longer exists. It even eradicated the disease in mouse models with established diabetes and blood sugars above 300 milligrams per deciliter.
“There is currently no treatment available that targets diabetes in this way,” Shalev says. “This addresses the main underlying cause of the disease — beta cell loss.”
“Currently, we can prescribe external insulin and other medications to lower blood sugar, but we have no way to stop the destruction of beta cells, and the disease continues to get worse,” says Fernando Ovalle, MD, Director of the UAB Multidisciplinary Comprehensive Diabetes Clinic. Ovalle, who helped develop the trial and will oversee its clinical aspects, says “if verapamil works in humans, it would be a truly revolutionary development.”
Funded by a three-year, $2.1 million grant from the JDRF– the largest nonprofit focused on type 1 diabetes research — the trial will likely be accepting participants through next summer. While enrolled in the trial, patients will be randomized to receive verapamil or a placebo for one year while continuing with their insulin pump therapy.
“This trial is based on a well-known blood pressure medication that has been used for more than 30 years and is unlikely to have any severe side effects,” Shalev says. She adds that it has been given to those without high blood pressure without any ill effects.
“This study is also backed by a lot of strong mechanistic data in different mouse models and human islets, and we already know the mechanisms by which verapamil acts,” she says. Unlike many other type 1 clinical trials, this one does not include any immunosuppressive or immune modulatory medications.
Despite an earlier insinuation by a TV media outlet, UAB’s verapamil trial is going strong. “It’s just going a little slower than we wish it were,” Shalev says. “We’re trying to build awareness. If you get a patient who has diabetes and doesn’t present as the classical type 2, think of type 1 diabetes. And tell them about the trial.”