A first-of-its kind trial in patients with type 1 diabetes is scheduled to get under way next year, in which researchers will try to reverse the disease process by attempting to increase beta-cell mass with the help of a common cardiovascular medication.
The team has already shown that verapamil, often used to control hypertension and arrhythmias, can not only prevent type 1 diabetes in mice but reverse severe established diabetes as well, the lead researcher, Dr Anath Shalev (University of Birmingham, Alabama [UAB]), stated this week.
The human trial, entitled, “The repurposing of verapamil as a beta-cell survival therapy in type 1 diabetes,” is expected to begin early in 2015 after more than a decade of research suggests that verapamil may be able to downregulate a key promoter of type 1 diabetes and bolster whatever dysfunctional beta cells remain in the pancreas, said Dr Shalev. The study will initially last a year.
“We…know that treatment definitely creates an environment where beta cells are allowed to survive, and their survival is a major factor in potentially improving insulin production, so our hope is that we’ll see a similar effect in type 1 diabetes patients to what we have seen in our mice models.”
Dr Shalev explained that over a decade ago, the UAB team was able to identify a protein called thioredoxin-interacting protein (TXNIP), which is dramatically increased in human islet cells in response to high glucose levels.
Since it’s known that hyperglycemia is toxic to beta cells, “we hypothesized that TXNIP might be involved in beta-cell death associated with diabetes.”
Furthermore, insulin resistance or any increased demand on the beta cell may also lead to elevated beta-cell TXNIP levels.
Researchers are planning to enroll 52 patients between the ages of 19 and 45 in the study, ideally within 3 months of being diagnosed with type 1 diabetes.
They will be randomized to either verapamil or placebo and will be treated for 1 year while continuing with insulin-pump therapy and employing continuous glucose monitoring.
However, she noted, “We’re not expecting any miracles with this study, since we will be treating patients for only 1 year, and we know that for any intervention to create an environment conducive to beta-cell survival or even regeneration after such a large number of beta cells have died will take a long time.”
The human study is being funded by JDRF, the largest charitable support of type 1 diabetes research
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