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Verapamil Diabetes Clinical Trial

Uab - News - Birmingham Woman Completes Year In Verapamil-diabetes Clinical Trial

Uab - News - Birmingham Woman Completes Year In Verapamil-diabetes Clinical Trial

Birmingham woman completes year in verapamil-diabetes clinical trial Recruitment for the trial continues as Myers discusses the benefits she received from participating and the knowledge she has gained to take control of her health care. As the year draws to a close, UAB News looks back at some of the top stories of 2016. See them all here . In November 2014, right about the time Birmingham resident Joy Myers was in an induced coma at an area hospital , the University of Alabama at Birmingham was on the verge of a clinical trial announcement that would bring Myers and UABs Comprehensive Diabetes Center together just a few weeks later. In human clinical trial, UAB to test drug shown to completely reverse diabetes in human islets, mice. The path to potential diabetes drugs began with a simple question . See an animation of how verapamil reverses diabetes in animal models. Regards data show diabetics who use verapamil have lower glucose levels . The announcement of the $2.1 million, JDRF-funded repurposing of verapamil as a beta cell survival therapy in type 1 diabetes was picked up around the world as the news was promising UAB research had shown the common blood pressure drug verapamil completely reversed diabetes in mice by lowering TXNIP levels in beta cells. With the first clinical trial to test whether it could do the same in humans just a few weeks away, Myers would become one of the first participants to take part in the potentially groundbreaking endeavor after doctors determined her body was in ketoacidosis brought on by type 1 diabetes. Myers recovered and recently wrapped up her yearlong participation in the blinded clinical trial; neither Myers nor her UAB doctors know yet whether she had the verapamil or the placebo. But those who do partake in the trial do Continue reading >>

Is Verapamil A Cure For Diabetes?

Is Verapamil A Cure For Diabetes?

Hello from Katherine, your War on Diabetes pharmacist. Last week news came out from the University of Alabama at Birmingham that is very promising for our Type 1 diabetics who are fighting their War. Researchers there have discovered that a commonly used medication for blood pressure, called verapamil, can actually improve and even reverse Type 1 diabetes in mice. Does this mean that a cure for millions of diabetics might have been sitting on pharmacy shelves all this time? Verapamil To answer that, let’s start by finding out how this discovery came to be. In previous research, it was discovered that high levels of a certain protein called TXNIP are produced when blood sugar levels are higher than normal. They also found that TXNIP in large amounts causes the death of beta cells. You remember beta cells, right? Those are the cells in the pancreas that are responsible for making our body’s insulin in response to high levels of blood sugar. In Type 1 diabetics, beta cells have been destroyed by the body’s immune system, so the body is not able to produce enough insulin to keep blood sugars under control. Researchers at the University of Alabama discovered that verapamil lowered levels of TXNIP in beta cells when given to mice. As a result, mice who had been determined to be diabetic, with glucose levels over 300 mg/dL, were found to have such a large decrease in levels of TXNIP when given verapamil that diabetes was actually eradicated! This is a very exciting prospect because it opens up a whole new area of research for prevention and treatment of diabetes. Verapamil is a relatively safe blood pressure medication that has been around for a number of years. If we could give it to diabetics to reverse the disease, the result would be incredible. For now, we will wait Continue reading >>

Improving Beta Cell Health And Survival

Improving Beta Cell Health And Survival

JDRF-funded clinical study to test marketed drug to improve beta cell health and survival in T1D JDRF recently awarded a $2.1 million grant to Anath Shalev, M.D., director of the University of Alabamas (UAB) Comprehensive Diabetes Center, to test the impact of a common blood pressure drug called verapamil on the health and survival of beta cells in people recently diagnosed with type 1 diabetes (T1D). Scientists have shown in the lab that stress on the beta cells, including high blood sugar and exposure to cytokines, causes the beta cells to produce high levels of a protein called TXNIP. TXNIP had previously been studied for its role in regulating cell death in response to stress, but its role in beta cell biology and the development of diabetes was not understood. Dr. Shalev and her team showed that too much TXNIP in the pancreatic beta cells leads to their death, diminishing the bodys ability to produce insulin. Scientists at UAB have also uncovered that the marketed drug called verapamil, which is used to treat high blood pressure, can lower TXNIP levels in beta cells to the point that, when mice with established diabetes and high blood sugars were treated with verapamil, the disease was reversed. Their work also suggested that verapamil may have beneficial effects in humans. The clinical trial is designed to determine if treatment with verapamil will improve the health and survival of the remaining beta cells in people with recent-onset T1D. The study is planned to enroll people within three months of receiving a T1D diagnosis. Participants will be randomized to receive verapamil or a placebo for one year while continuing with their existing insulin therapy. In addition to monitoring safety outcomes, the trial will look for changes in metabolic control and markers Continue reading >>

First Human Data Show Verapamil Lowers Glucose In Diabetes

First Human Data Show Verapamil Lowers Glucose In Diabetes

First Human Data Show Verapamil Lowers Glucose in Diabetes In the first study to examine whether the calcium-channel blocker verapamil lowers glucose in humans ( as it does in mice ), this old drug that has long been used to treat hypertension, cardiac arrhythmia, and migraine was indeed associated with a lower fasting serum glucose in diabetic patients. The observational study of a subset of close to 5000 patients who had diabetes and were participating in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study, by Dr Yulia Khodneva, from the University of Alabama at Birmingham (UAB), and colleagues, was published online February 12 in Diabetes Research and Clinical Practice. Among these patients who had type 1 diabetes or late-stage type 2 diabetes (ie, were taking insulin or insulin plus an oral antidiabetic agent), those who also received verapamil had fasting serum glucose levels that were 24 mg/dL lower than their peers who were not receiving verapamil (P = .039). This 24-mg/dL difference in fasting serum glucose is "dramatic," since it is roughly equal to an HbA1c drop from 8% to 7% (where 7% is the American Diabetes Association treatment target), Dr Khodneva told Medscape Medical News. However, the current study is observational and very preliminary, she stressed. More answers should be forthcoming about 18 months from now when results start to emerge from "the repurposing of verapamil as a beta-cell survival therapy in type 1 diabetes" randomized controlled trial that fellow researchers at UAB are conducting. That study has so far enrolled 20 adults aged 18 to 45 with recent-onset type 1 diabetes (of a planned enrollment of 52 such patients), to see whether 12 months of daily oral verapamil will improve insulin production. "I think that if Continue reading >>

Blood-pressure Drug Could Be A Possible Type 1 Diabetes Cure

Blood-pressure Drug Could Be A Possible Type 1 Diabetes Cure

A common blood pressure drug is showing new promise to help treat and cure type 1 diabetes. To imagine that a blood pressure drug, that has been around for more than 25 years and has a generic, could possibly be a cure for type 1 diabetes is almost too much to believe. The study is now just beginning. Researchers have discovered that the drug verapamil reversed type 1 diabetes in mice, so they will now be testing it in humans. Dr. Anath Shalev, one of the researchers, discovered that verapamil can also protect beta cells. If this is shown to be correct, it would be the first treatment that could promote the patient’s own beta cell mass and improve function. And, since verapamil is already FDA approved for blood pressure, it could become available very quickly if the study is successful. This could make a major difference for people with type 1 diabetes. This would be a first of its kind trial for those with type 1 diabetes. The verapamil diabetes study, which will begin shortly, will use the current canadian pharmacy ratings to reverse the destruction of the beta cells. The trial will be entitled, “The repurposing of verapamil as a beta-cell therapy for type 1 diabetes.” It should begin the first quarter of 2016 and will last for a year. The best results of the trial would be for researchers to see the same effect in humans as they have seen in mice. The studies in mice indicate that treatment creates an environment where beta cells are allowed to survive, and their survival is a major factor in potentially improving insulin production. So the hope for the researchers is that at the end of the study a similar effect in type 1 diabetes patients is demonstrated. Dr. Shalev explained that over a decade ago, the UAB team was able to identify a protein called thioredox Continue reading >>

Data Show Diabetics Using Verapamil Have Lower Glucose Levels

Data Show Diabetics Using Verapamil Have Lower Glucose Levels

Newsroom Published on: February 12, 2016 Data Show Diabetics Using Verapamil Have Lower Glucose Levels The results amplify earlier work at UAB that showed verapamil reversed type 1 diabetes in mice. A clinical trial involving the drug in recently diagnosed patients with type 1 disease is still enrolling participants. A researcher at the University of Alabama at Birmingham (UAB) has found that diabetics who took the blood pressure medication verapamil during a large-scale study had lower fasting blood glucose levels than other participants. The findings, published in Diabetes Research and Clinical Practice, follow work that showed verapamil reversed diabetes in mice with type 1 diabetes (T1D), and create anticipation for results of a clinical trial now under way at UAB. Yulia Khodneva, MD, PhD, a research associate at UABs Comprehensive Diabetes Center, examined how calcium channel blockers, including verapamil, affected fasting serum glucose in a cohort of adults who were part of a broader study known as REGARDS. Reasons for Geographic and Racial Differences in Stroke project, which is sponsored by the National Institutes of Health, is a 5000-person study seeking insights on cardiovascular risk factors. Khodneva and colleagues focused on 1484 patients who used calcium channel blockers (CCB), including 174 who used verapamil. They found that while all users of the CCBs experienced serum glucose levels that were 5mg/dL compared with the others, those who used verapamil had particular good results: 10 mg/dL lower serum glucose compared with CCB non-users. Among insulin users, the results with verapamil were profound: users had 24 mg/dL lower serum glucose than insulin users who also used oral agents, and 37 mg/dL lower than those who used insulin alone. The change in gluc Continue reading >>

Clinical Trial Tests Drug Shown To Completely Reverse Diabetes

Clinical Trial Tests Drug Shown To Completely Reverse Diabetes

Clinical Trial Tests Drug Shown to Completely Reverse Diabetes Authors: Tyler Greer Faculty and Disclosures New research conducted at the University of Alabama at Birmingham (UAB) has shown that the common blood pressure drug verapamil completely reverses diabetes in animal models. Now, thanks to a three-year, $2.1 million grant from the Juvenile Diabetes Research Foundation (JDRF), UAB researchers will begin conducting a potentially groundbreaking clinical trial in 2015 to see if it can do the same in humans. The trial, known as the repurposing of verapamil as a 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. The trial will test an approach different from any current diabetes treatment by focusing on promoting specialized cells in the pancreas called cells, which produce insulin the body needs to control blood sugar. 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 cell biology. Too much TXNIP in the pancreatic cells leads to their deaths and thwarts the body's efforts to produce insulin, thereby contributing to the progression of diabetes. Still, 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 cells -- to the point that when mouse models with established diabetes and blood sugars above 300 mg/dL were treated with verapamil, the disease was eradicated. "We have previously shown that verapamil c Continue reading >>

Possible Cures For Type-1 In The News (december)

Possible Cures For Type-1 In The News (december)

Here are some "bits and pieces" updates for December. Update on Dr. Faustman's Phase-II Trial of BCG Dr. Faustman's lab has published their Fall 2017 newsletter, which you can read here: This newsletter includes more information on her research, especially from the 3rd International BCG conference, The BCG Working Group, and the 2nd edition of the BCG and Autoimmunity book she edited. There are three pieces of new news there: The phase-II trial was fully enrolled in Summer of 2017. This is important because we now know when the trial will end. Since this is a five year study, they should finish collecting data in Summer of 2022 and publish before Summer of 2023. They have given BCG to the three untreated patients from their phase-I trial, so they will have data from six people to report in the future. The lab is going to be recruiting for more studies in the future, so would like to hear from anyone who is interested in participating. No details on future trials were provided. Another piece of news is that Dr. Faustman is branching out, and trying to apply BCG treatment to Fibromyalgia. This research is being done in collaboration with EpicGenetics, and they hope to start the trial in early 2018. If anything applicable to the type-1 world comes up in this research, I'll report it. Since Fibromyalgia is not generally considered an autoimmune disease, I'm not sure how much "cross pollination" of results there will be. You can read more about it here: DILfrequency Trial Completed There is a lot of research ongoing on IL-2 which is part of the immune system. About 18 months ago, I summarized all this research here: with an update here: One of those clinical trials was called "DILfrequency" and that trial has finished, and the results published. The purpose of that trial was Continue reading >>

Human Trial Underway For Drug That Reverses Type 1 Diabetes In Mice

Human Trial Underway For Drug That Reverses Type 1 Diabetes In Mice

Human trial underway for drug that reverses type 1 diabetes in mice Debby LaCruz works out at the downtown YMCA in Birmingham, Ala., on Tuesday, Jan. 18, 2011. LaCruz, who has had Type 1 diabetes since she was 19, is the coordinator of YMCA's Diabetes Prevention Program. She wears a continuous insulin drip at her waist and is currently training for a triathlon in June. (The Birmingham News / Michelle Campbell) (Michelle Campbell) Researchers at UAB are seeking adult participants for a trial of a drug that has shown great promise in treating mice affected by type 1 diabetes. The drug, verapamil, has been on the market for more than 30 years as a treatment for high blood pressure. Dr. Anath Shalev, director of UAB's Comprehensive Diabetes Center, has spent years studying the drug's potential as a treatment for type 1 diabetes. Verapamil cured the disease in some UAB studies of mice. Type 1 diabetes occurs when the immune system attacks beta cells in the pancreas that produce insulin to control blood sugar. When about 80 percent of those cells have been destroyed, blood sugar levels start to rise and patients begin showing symptoms of the disease, said Dr. Fernando Orvalle, an endocrinologist at UAB and a researcher in the study. Researchers hope verapamil may help prevent the death of the remaining beta cells, and even restore function to some that have been damaged. That will help patients retain some pancreas function to control the symptoms of diabetes. "It would really make a huge difference in the lives of those with diabetes," Orvalle said. We know that patients with some pancreas function, they do better. They have less low blood sugars and fewer complications." Right now, researchers are recruiting adults between the ages of 19 and 45 who have been diagnosed with Continue reading >>

Possible Cures For Type-1 In The News (november)

Possible Cures For Type-1 In The News (november)

Possible Cures for Type-1 in the News (November) Possible Cures for Type-1 in the News (November) Ustekinumab, an immune modulating drug, started a Phase-II? trial in July 2014. I previously blogged about it here: They completed enrollment on May 24, 2016, which means they should finish gathering data by May 24, 2017, because they need to gather data for a year. Successful results are usually published in less than a year after completion. This drug was approved in the US in 2009 for treating psoriasis, which is an autoimmune disease (where the immune system self attacks skin cells rather than pancreas cells, as with type-1). It has also been tested on multiple sclerosis, Crohn's disease, and sarcoidosis (also all autoimmune diseases). Ustekinumab is thought to work by blocking inflammation, and specifically blocking two immune molecules called IL-12 and IL-23. Clinical Trial Record: In July, A Phase-II? Verapamil Trial Was 20% Enrolled A research group at the University of Birmingham (Alabama) is testing Verapamil on people in the honeymoon period. The hope is that Verapamil will cause beta cells to naturally regrow. I've previously blogged on this research here: They have been recruiting for over a year, but have only enrolled 12 people, out of the 52 they need. At this rate, they will not be fully enrolled within 2 years as they had hoped, and that's a problem. The drug they are testing is already approved (and pretty widely used) for high blood pressure, so it should not be that hard to recruit for this study. However, only adults can be recruited (per FDA rules). Obviously, limiting recruitment to adults still in their honeymoon phase makes this process much more difficult, since most honeymooners are youth, not adults. Terminated: Leptin by Garg at University of Continue reading >>

Current Research Into Cures For Type-1 Diabetes

Current Research Into Cures For Type-1 Diabetes

Current Research into Cures for Type-1 Diabetes News and updates on potential cures for type-1 diabetes, that are in human (or clinical) trials. Soundtrack is "I'm Bad, I'm Nationwide" by ZZ Top: Verapamil is a drug which has been used in the US since 1982 for high blood pressure, migraines, and heart problems. It also lowers levels of a protein called TXNIP. The researchers running this trial believe this is important because they believe TXNIP kills beta cells as part of the onset of type-1 diabetes. So giving Verapamil should lower TXNIP which should improve beta cell survival, and stop type-1 diabetes. In addition TXNIP is known to lower inflammation, and that might have an effect on type-1 diabetes as well.TXNIP worked in mice trials (but see discussion below). Drs. Anath Shalev and Fernando Ovalle at the University of Alabama at Birmingham have started a clinical trial. They are enrolling 52 adult, honeymoon type-1 diabetics; half will be treated, half are a (double blind) placebo control group. Patients will get Verapamil for a year, at the same doses that it is commonly prescribed. The primary end point is C-peptide levels after a meal. The researchers will also track several other outcomes: insulin usage, A1Cs, TXNIP, beta cell markers, glucose generation, and two measures of BG stability. They expect to finish in July 2017, which breaks down to about 1 1/2 years to recruit all the patients, and 1 year to run the trial. This study is funded by JDRF, and is being conducted at TheUniversity of Alabama at Birmingham. Contact information is: Tiffany H Grimes, RN 205-934-4112 [email protected] Kentress Davison 205-934-4112 [email protected] Wikipedia: There is a lot to like about this trial. Using an already approved drug means they don't need to do a phase-I trial; Continue reading >>

Human Clinical Trials To Begin On Drug That Reverses Diabetes In Animal Models

Human Clinical Trials To Begin On Drug That Reverses Diabetes In Animal Models

Human clinical trials to begin on drug that reverses diabetes in animal models Clinical trials are set to begin in 2015 on the potential of a common blood pressure drug for treating diabetes (Photo: Shutterstock ) A study at the University of Alabama at Birmingham (UAB) has shown that verapamil, a drug widely used to treat high blood pressure, irregular heartbeat and migraine headaches, is able to completely reverse diabetes in animal models. The UAB team will now move onto clinical trials to see if the same results are repeated in humans. Following years of research, the UAB researchers have shown that high blood sugar causes the body to overproduce a protein called TXNIP. Too much of this protein in specialized cells in the pancreas called beta cells contributes to the progression of diabetes by leading to the death of the cells and countering the body's efforts to produce insulin. The researchers found that verapamil can lower the levels of TXNIP in pancreatic beta cells to the point that the disease was eradicated in mouse models with established diabetes and blood sugar levels over 300 mg per deciliter. The team has also shown that verapamil reduces TXNIP levels in human islet beta cells, suggesting the same beneficial effects will carry over to humans. "That is a proof-of-concept that, by lowering TXNIP, even in the context of the worst diabetes, we have beneficial effects," said Anath Shalev, M.D., director of UABs Comprehensive Diabetes Center. "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 patients own beta cell mass and insulin production. There is currently no treatment available that targets diabetes in this way." To test whether the drug is effective in Continue reading >>

Verapamil For Beta Cell Survival Therapy In Type 1 Diabetes

Verapamil For Beta Cell Survival Therapy In Type 1 Diabetes

You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Verapamil for Beta Cell Survival Therapy in Type 1 Diabetes The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT02372253 Recruitment Status : Active, not recruiting Information provided by (Responsible Party): Fernando Ovalle, University of Alabama at Birmingham Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information The overall purpose of this trial is to assess the efficacy and safety of using oral verapamil in subjects with recent onset T1D in order to downregulate TXNIP and enhance the patients' endogenous beta cell mass and insulin production. The objectives are therefore to assess parameters of beta cell survival (including new biomarkers), insulin production and glucose control and the feasibility of this approach and thereby provide the basis for future, larger/expanded, longer-term verapamil studies and the off-label use of this approved drug for T1D. Loss of pancreatic beta-cell mass is a key factor in T1D, but therapies to halt this process are not available. The investigators have discovered thioredoxin-interacting protein (TXNIP), as a promising target in this regard and have now found that the commonly used anti-hypertensive drug and calcium channel-blocker, verapamil, effectively lowers beta-cell TXNIP expression in rodent beta-cells and human islets, promotes beta-cell survival and rescues mice from T1D. This makes verapamil a potentially attractive drug for T1 Continue reading >>

Verapamil In Diabetes

Verapamil In Diabetes

Department of Internal Medicine, Western Reserve Health Education, Youngstown, OH, USA 1Department of Public Health, Institute of Medicine, Kathmandu, Nepal Address for correspondence: Dr. Resham Raj Poudel, Western Reserve Health Education, Youngstown, OH, USA. E-mail: [email protected] Author information Copyright and License information Disclaimer Copyright : 2017 Indian Journal of Endocrinology and Metabolism This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. Loss of pancreatic cells is a pathological hallmark of both type 1 and type 2 diabetes mellitus; however, no specific therapy targeting this defect is yet available. A paradigm shift with such a molecule has always been awaited. Verapamil a nondihydropyridine calcium channel blocker used in the treatment of hypertension, angina, and tachyarrhythmias, particularly atrial fibrillation has been observed to show some hope in preventing cell loss in diabetics by inhibiting thioredoxin-interacting protein (TXNIP). TXNIP was first cloned in 1994 and the relation with cells was elucidated in 2002. Pancreatic cells have a poor antioxidant system and are highly susceptible to oxidative stress. TXNIP inhibits thioredoxin a redox protein/antioxidant system [ Figure 1 ],[ 1 ] and thereby induces oxidative stress. cells TXNIP expression is strongly induced by glucose and is increased in diabetes. The overexpression of TXNIP in cells has been shown to promote cell apoptosis and reduce insulin production,[ 2 ] as shown in [ Figure 1 ].[ 1 ] Genetic deletion or pharmaco Continue reading >>

Verapamil For Beta Cell Survival Therapy In Type 1 Diabetes

Verapamil For Beta Cell Survival Therapy In Type 1 Diabetes

Verapamil for Beta Cell Survival Therapy in Type 1 Diabetes The overall purpose of this trial is to assess the efficacy and safety of using oral verapamil in subjects with recent onset T1D in order to downregulate TXNIP and enhance the patients' endogenous beta cell mass and insulin production. The objectives are therefore to assess parameters of beta cell survival (including new biomarkers), insulin production and glucose control and the feasibility of this approach and thereby provide the basis for future, larger/expanded, longer-term verapamil studies and the off-label use of this approved drug for T1D. triple (participant, care provider, investigator) 13-26 subjects with Type 1 Diabetes meeting the inclusion criteria will be randomly assigned to receive daily oral verapamil for 12 months. The initial dose of verapamil will be 120 mg daily, and this will be advanced if tolerated to a maximum dose of 360 mg daily. The verapamil tablets will be encapsulated to match the placebo capsules 13-26 subjects with Type 1 Diabetes meeting the inclusion criteria will be randomly assigned to receive daily oral placebo for 12 months. The initial dose of placebo will be 120 mg daily, and this will be advanced if tolerated to a maximum dose of 360 mg daily. The placebo tablets will be encapsulated to match the verapamil capsules All participants from 18 years up to 45 years old. Inclusion Criteria: - Subjects must meet all of the following criteria: - Diagnosis of Type 1a Diabetes Mellitus based on ADA Criteria - Written informed consent obtained from the subject including consent for the use of research-related health information - 18 years of age and 45 years of age - < 3 months since T1DM was diagnosed - BMI < 30 - Baseline A1c <10% - Detectable fasting or stimulated C-peptide l Continue reading >>

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