A vaccine may stop the development of diabetes

Israel is estimated to have about 400 diabetics and here, as in the Western world, there is great concern about the disease approaching epidemic proportions. A series of studies and raising awareness of the disease give rise to hope for an improvement in the situation

Broria Ether, Haaretz, from the Walla!

insulin syringes. Israeli scientists succeeded in creating cells that secrete insulin for the first time in the world

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A vaccine that may halt the development of juvenile diabetes has been successfully tested at Hadassah Hospital in Jerusalem. It has been proven that as long as the vaccine is given, it may stop and delay the development of the disease. The vaccine was developed in the immunology department of the Weizmann Institute by Prof. Yaron Cohen and Dr. Dana Elias. After proving its success in laboratory animals, it was tested on Hadassah patients.

About 25 patients with juvenile diabetes are currently registered in Israel. The disease, which usually appears before the age of 20, is due to the fact that cells of the immune system attack the pancreas and destroy beta cells, the ones that secrete insulin, which is the hormone responsible for breaking down sugars in the body. In the advanced stages of the disease, there is a total destruction of the cells, which causes a complete lack of insulin in the body. The mechanism of action of the vaccine is based on a protein that neutralizes the cells of the immune system that attack the pancreatic cells and causes them to stop killing. The researchers who discovered the protein isolated a small component of it, injected it into mice that were infected with the disease and the inflammatory process that damages the pancreas was stopped.

The first results of the vaccine in humans were published about two years ago and were presented at an international scientific conference held in Jerusalem. They showed that injecting it prevented the attack on the cells that produce insulin. 35 patients participated in this experiment, half of whom received the vaccine for 10 months. The rest were injected with a placebo. Indeed, in the patients who received the vaccine developed at the Weizmann Institute, it became clear that the attack on the cells had stopped. Therefore, the experiment was extended to a period of 18 months and then to 30 months. The results of all the tests were unequivocal, notes Prof. Itamar Raz, president of the Israeli Diabetes Association. Those who received the vaccine were stable and kept the cells - the beta cells - that they had when the treatment began. In other words: the development of the disease slowed down. Whereas in the patients who received a placebo, the cell destruction continued and their pancreas completely stopped producing insulin.

According to Prof. Raz, the disease is usually discovered in quite late stages, when the patient has only 10% of the cells left in the pancreas. Therefore, even if you manage to stop the disease with the vaccine, a large part of the patients still have to continue and receive insulin from an external source. Because, unlike animals, humans do not know how to recreate the beta cells that produce the hormone, so diabetes develops quite quickly. However, out of the several dozen patients who participated in the study, two stopped injecting insulin and they manage to maintain the sugar balance for the time being.

It is important to balance the diabetes in the early years of the disease, because then the damage in later years will be less dramatic. Because, in its advanced stages, diabetes can cause many complications, including heart problems, arteriosclerosis, damage to the nervous system, eyes and kidneys. If the experiments continue and the effectiveness of the vaccine is proven, it will be possible in the future to stop the disease before irreversible destruction is caused. Already today, says Prof. Raz, there is a simple blood test to test for antibodies in the pancreas that may predict the outbreak of the disease in the future.

The vaccine, given by injection four times a year, is still in the research phase. Therefore, it is not yet available to everyone and can only be obtained through participation in experiments.

Review for data at risk

The continuous increase in the number of adult diabetes patients, type 2 diabetes, in Western society, is approaching epidemic proportions and worries the health authorities in all Western countries, including Israel, says Dr. Julio Weinstein, director of the diabetes unit at Wolfson Hospital in Holon and vice president of the Israel Diabetes Association. The accepted assumption is that the number of treated diabetics is around 250 thousand, and that there are another 150 thousand who have not been diagnosed and are unaware of their condition; So it is about 400 thousand diabetics. According to the World Health Organization, in 2010 there will be approximately 250 million patients worldwide; 90% of them will be type 2 diabetics. Already today, says Dr. Weinstein, 20% of those hospitalized in hospital internal wards are diabetics, as are many of those suffering from heart attacks, high blood pressure and strokes. Therefore, the health authorities invest a lot of effort in the field of prevention. It has been proven in many studies, notes Dr. Weinstein, that moderate physical activity, walking for 22 minutes a day, may prevent diabetes in 58% of cases. A weight loss of around 7% of the existing weight has also been shown to be effective.

Dr. Weinstein hopes that as a result of the association's activities, the State of Israel will be able to be among the first to have a policy that prevents diabetes. He emphasizes the matter of educating the population from childhood. "The source of all problems, if we neutralize the matter of heredity of course, is poor nutrition. When a child cries, they give him sweet food to calm him down and thus he gets used to harmful eating habits." The same goes for the high fat percentages in cheeses, for example. In Dr. Weinstein's opinion, the Ministry of Health should ban the marketing of cheeses containing more than 10% fat.

Among the preventive actions, the Diabetes Association offers tests for the early detection of the disease for the entire population and especially for people at risk. Recently, a simple prediction model was developed to identify people at high risk of developing diabetes. Those with risk factors are 45 years old with a BMI (body mass index) over 25, abdominal obesity, a family history of diabetes, high fasting glucose, high blood pressure and a high level of triglycerides (blood fats). Also included in the risk group, says Dr. Weinstein, is any woman who gave birth to a baby over 4 kg or who had gestational diabetes. The recommendation is to carry out the review once every three years. According to Dr. Weinstein, it is of the utmost importance not only to detect diabetes early, but also to identify and discover the intermediate metabolic states, in which there is a disturbance in carbohydrate metabolism, that is: an abnormal metabolic state that has not yet developed into actual diabetes.

Acceleration for stem cell research

The treatment of the disease is medicinal and aims to balance the insulin levels, but it is not curative. Since the main cause of diabetes is the loss of cells that secrete insulin, one of the leading topics in the research of the disease today is the development of innovative drugs that will cause the creation of cells and prevent their destruction, as well as the search for alternatives to destroyed cells. Prof. Raz points out that replacements for insulin-secreting cells may be converting liver cells into insulin-secreting cells, or taking stem cells and turning them into insulin-producing cells. Regarding the liver cells, there is currently a way to turn them into pancreatic cells by transplanting the gene that secretes insulin.

As for stem cells, the topic has recently gained a lot of momentum. Many scientists joined the growing community of stem cell practitioners, and a wealth of new research was published that improved the understanding of the cell. The problem is how to direct the differentiation of embryonic stem cells into pancreatic or liver cells that have healing potential. Israeli scientists are among the leaders in a field that is gaining momentum. A significant step in this direction was made at the Technion's Rapoport Institute, where researchers were able for the first time to grow human embryonic stem cells under special conditions and identify insulin-secreting cells among them. The work was done by Dr. Sohir Asadi from the Faculty of Medicine at the Technion, under the guidance of Prof. Karl Skortsky, director of the Rapoport Institute. The work of the Israeli researchers is the first successful attempt of its kind to create insulin-secreting cells from a source other than the pancreas. This is a first step on the way to producing insulin-secreting human stem cells, which could be used in the future to cure diabetes.

Embryonic stem cells are taken from embryos a few days old at a stage when the cells have the ability to transform into different tissue types. Using a chemical effect, the researchers were able to direct the development of the embryonic stem cells towards insulin-secreting cells.

A complete cure is now possible through a whole pancreas transplant or a beta cell transplant separated from the whole pancreas. Transplantation attempts from a donor are successfully performed with increasing frequency in recent years. However, Prof. Raz adds, the pancreatic cells must be taken from humans, and as in all fields of transplantation, there is a shortage of donors. In Israel the situation is even worse since the Transplantation Law allows the taking of organs only for the purpose of saving life and the criteria are strict.

Don't know, don't check

Until a cure is found for the disease, its most common complication is hypertension, from which 57% of patients suffer. After that - excess lipids in the blood, found in 36% of patients, and foot problems, 26%. This is according to a survey conducted by Aventis, the manufacturer of the insulin drug Lantus. The survey was conducted by the Geocartography company and included 200 diabetic patients, who are a representative sample of the patients in Israel. In addition, 22% of the respondents stated that they have heart disease, 18% suffer from eye problems, and 12% said that they have kidney problems. However, only about a quarter of the patients knew that heart attacks were a complication of diabetes, even though heart problems are the most significant cause of death among these patients.

According to the survey, 54% of diabetes patients are not at all familiar with the essential test to determine the balance status of their disease. This is the glycated hemoglobin test, which is a measure of the quality of the balance of the sugar levels. A level higher than 8% significantly increases the risk of stroke, blindness, amputation and heart attacks. The survey revealed that 33% of those who know their glycated hemoglobin level are at the 8% higher level, that is, they have a high risk of suffering from serious diseases. The findings of the survey show that only half of the diabetics who knew about the test perform it every three months as required, although it is included in the health basket and is given free of charge to diabetics.

43% of patients are anxious

Another facet of the disease is shared by 43% of those with it - who are constantly anxious about the worsening of their disease state. 47% of these patients have difficulty coming to terms with the fact that this is a chronic disease that cannot be fully cured. This is according to a recent international survey conducted in 13 countries in the world, including the United States, Australia, India, Japan and Denmark. About 5,500 patients, 2,200 doctors, 550 endocrinologists and diabetologists and about 1,100 general and specialist nurses participated in the survey, called "Wishes and Needs" (DAWN), "Diabetes Attitudes" and done in collaboration with the International Diabetes Foundation.

Dr. Ilana Herman, director of Internal Medicine Department C and the Diabetes Metabolism Unit at the Soroka Medical Center, states that the anxiety and the mental state in which the patient is, as it became clear from the survey, also affect the metabolic balance. Beyond medication, diet and physical activity, the mental aspect of the disease must be dealt with, since socio-psychological barriers in the staff and in the patient harm, according to the survey, the success of the treatment. Although this has been known to doctors treating diabetes for years, the study refined and focused the problem, especially since this is the first time that the study included not only the patients but also the entire treating staff, including nurses and "diabetes educators".

Diabetes educators is not just a title for the sake of recommendation. In the United States this is a common and accepted profession and in Israel it is starting to gain momentum. The first courses began back in 1995 and today there is already a fairly large group of course graduates who apply the field in their work. Dr. Harman explains: "We are familiar with the 'scary white coat' effect, one of its manifestations is the increase in blood pressure in a patient due to the meeting with the doctor. On the other hand, the effect is more moderate when visiting the nurse, and the expectation is that the patient will open up more to the nurse than to the doctor and feel freer. That is why they started training 'diabetes educators', staff members who are not doctors, such as nurses, dieticians and social workers, and recently the pharmacists were also added to this. Their role is to be attentive to the patient's needs, provide him with information, guide him to a healthy lifestyle, reassure and encourage him. Yes, a depressed and tense patient - his condition will only worsen, as in other chronic diseases."

These words are consistent with the findings of the aforementioned study, which was initiated by the pharmaceutical company Novo Nordisk. One of his important conclusions, according to Dr. Herman, is that "diabetes, more than any other chronic disease, will be effectively managed only when the entire multi-professional team is coordinated." And, "Improvement in balance and results will be achieved by focused psychosocial support, in combination with appropriate medication." The researchers also emphasize the matter of "self-management", for the achievement of which the patients need social support and mental health. Dr. Herman points out that diabetes is a disease that the patient has to deal with 24 hours a day, so correct self-management is important, if also with the help of a supportive company, family, community and medical staff.

One of the most serious problems in the eyes of diabetics is the transition to insulin treatment. According to the survey, 55% of these patients believe that if the doctor switches them to insulin treatment, this indicates that they did not treat their disease properly, did not maintain a diet and take medication, and the switch to insulin is seen as their punishment.

The problem, says the study, begins with the family doctors, who in many cases define the diabetes as mild and not related to insulin. According to the survey, during the transition to insulin treatment, the patient feels a loss of control, a failure, and feels in danger of becoming terminally ill. According to Dr. Herman, this is the result of a previous approach that still exists in some places, according to which doctors warned patients to maintain a balanced diet and let them understand that if they were forced to switch to insulin injections, it was a sign that they did not follow the doctor's instructions.

Today the attitude has changed. Most people with diabetes, especially adult diabetes, understand that this is a serious disease with complications, in which there is a lack of insulin activity and over time a noticeable decrease in insulin secretion. Therefore, as the disease progresses, some patients need additional insulin, even if they have followed all the doctor's instructions related to diet and lifestyle. "This is not a punishment, but a natural process," says Dr. Herman.

The fear of insulin stems not only from the injection but also from the patient's fear of becoming a disabled and addicted person. This fear can be eradicated through "finding the psychological barriers of patients and caregivers to insulin treatment and dealing with them" - the language of the study. The researchers also determined that, like the general anxiety that often accompanies diabetes patients, so too "the fear of insulin treatment is certainly one of the causes of a state of insufficient balance". Moreover, the insulin resistance may cause non-medical considerations to influence the way pure medical decisions are made.

Among other things, the researchers recommend that the treatment team share the responsibility for treatment with the patient himself and encourage him to be as independent as possible. However, the study recommends intensive and maximum balance - "without compromises and excuses" - and treatment by a multidisciplinary team, which is more effective in balancing diabetes than treatment by a doctor alone.

When do you need insulin?

Insulin is the hormone responsible for balancing blood sugar levels and is active in various processes related to metabolism in the body. Diabetes affects the production and absorption of insulin in the body. In type 1 diabetes, known as juvenile diabetes, insulin production in the body is completely stopped, because the body's immune system works against these cells. Those with this type of the disease are treated exclusively with external insulin. Type 2 diabetes, which is the more common disease, is caused by various reasons such as obesity, lack of physical activity as well as family background. In type 2 diabetes, the damage is gradual, so the insulin treatment is not immediate.

About a quarter of diabetics in Israel are treated with insulin injections and the rest with pills. However, experts now claim, including Prof. Itamar Raz, head of the Diabetes Association, that it is appropriate to start insulin treatment in the early stages to improve the balance of the disease. It seems that insulin treatment in Israel does not start early enough. 90% of diabetics who are not treated with insulin claim that they were never offered such treatment.

Balance alone

A study involving more than 7,000 patients and carried out in more than 1,000 medical centers in 62 countries, including Israel, found that diabetic patients are able to change their insulin doses independently, without the need for close guidance from a doctor.

Patients with severe diabetes with an A1C index (glycated hemoglobin) above 7 and below 12 participated in the study. The study is based on the insulin Lantus. According to Prof. Raz, this is the best insulin, which allows the doctor and the patient to imitate the natural state in humans, where basic insulin is secreted at a constant level during the day, and during meals - an additional amount to introduce the extra sugars into the cells.

The study included type 1 (juvenile diabetes) and type 2 diabetes patients, who were divided into groups. Some of the patients came for a weekly personal meeting with the doctor, while other patients received instruction on how to change the drug doses and did so independently based on self-measurements.

Until today, determining the dose of insulin was considered a skill that should be left in the hands of the doctor only, due to the many risks. The ability to reduce the number of visits gives the patient empowerment and a feeling of control over the disease without being dragged into the constant fear of hypoglycemia.

The patients were followed up for 24 weeks. The results of the study showed that there was no difference between the two groups. The patients who determined their insulin doses themselves did so with similar success rates as those whose dose was monitored by the doctor. With both treatment methods, a decrease in the level of glycated hemoglobin was achieved and the patients' balance was improved, which allows the patients to lead a normal lifestyle.

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