A common blood pressure drug could be the key to reversing diabetes, researchers have said.
Called verapamil, it is widely diagnosed to treat blood pressure, irregular heartbeat and migraines.
Researchers were stunned to find that in mice, it completely reversed the effects of the disease.
HOW THE TRIAL WILL WORK
The trial will enroll 52 people between the ages of 19 and 45 within three months of receiving a diagnosis of type 1 diabetes.
Patients
enrolled will be randomized to receive verapamil or a placebo for one
year while continuing with their insulin pump therapy.
In
addition, they will receive a continuous glucose monitoring system that
will enable them to measure their blood sugar 24 hours a day, seven
days a week.
The University of Alabama at Birmingham has now been given a three-year, $2.1 million grant to begin human trials of the drug.
'We
have previously shown that verapamil can prevent diabetes and even
reverse the disease in mouse models and reduce TXNIP in human islet beta
cells, suggesting that it may have beneficial effects in humans as
well,' said Anath Shalev,of UAB's Comprehensive Diabetes Center, who is
leading the trial.
The
trial, known as 'the repurposing of verapamil as a beta cell survival
therapy in type 1 diabetes,' is scheduled to begin early next year and
has come to fruition after more than a decade of research efforts in
UAB's Comprehensive Diabetes Center.
Type 1 diabetes is usually diagnosed in children and young adults, and was previously known as juvenile diabetes.
Only 5% of people with diabetes have this form of the disease, when the body does not produce insulin.
The trial will test an approach different from any current diabetes treatment by focusing on promoting specialized ce
UAB
scientists have proved through years of research that high blood sugar
causes the body to overproduce a protein called TXNIP, which is
increased within the beta cells in response to diabetes, but had never
previously been known to be important in beta cell biology.
Too
much TXNIP in the pancreatic beta cells leads to their deaths and
thwarts the body's efforts to produce insulin, thereby contributing to
the progression of diabetes.
DIABETES IN THE US
Diabetes,
which is the nation's seventh-leading cause of death, raises risks for
heart attacks, blindness, kidney disease and limb amputation.
Recent
federal government statistics show that 12.3 percent of Americans 20
and older have diabetes, either diagnosed or undiagnosed.
Another 37 percent have pre-diabetes, a condition marked by higher-than-normal blood sugar, up from 27 percent a decade ago.
While
a new report in the Journal of the American Medical Association showed
rates at which new cases are accumulating have slowed in recent years,
the numbers remain high and are still increasing overall, with 8.3
percent of adults diagnosed with the disease as of 2012.
And
no slowing of the disease has been seen in new cases among blacks and
Hispanics or in overall rates among people with high school educations
or less.
Plus, the annual cost to treat the disease is exorbitant — and rising.
The American Diabetes Association reports that the disease cost the nation $245 billion in 2013.
But
UAB scientists have also uncovered that the drug verapamil, which is
widely used to treat high blood pressure, irregular heartbeat and
migraine headaches, can lower TXNIP levels in these beta cells — to the
point that, when mouse models with established diabetes and blood sugars
above 300 milligrams per deciliter were treated with verapamil, the
disease was eradicated.
'That is a proof-of-concept that, by lowering TXNIP, even in the context of the worst diabetes, we have beneficial effects.
'And all of this addresses the main underlying cause of the disease — beta cell loss.
'Our current approach attempts to target this loss by promoting the patient's own beta cell mass and insulin production.
'There is currently no treatment available that targets diabetes in this way.'
UAB
researchers will begin conducting a potentially groundbreaking clinical
trial in 2015 to see if it can do the same in humans.
Researchers
have known for some time that beta cells are critical in type 1 and
type 2 diabetes. The cells are gradually lost in both types of the
disease due to programmed cell death, but the exact triggers for the
deaths were previously unknown.
Somewhat
surprisingly, it was also noted that, after years — decades, even — of
living with type 1 diabetes, where beta cells were thought to be
completely destroyed early on by the autoimmune process, patients still
had a measurable amount of beta cell function; it just was not enough to
maintain a normal blood sugar.
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