FAQ'S for adults
Aspartame
Aspartame (Nutrasweet) is one of the intense sweeteners used widely in foods, beverages and also as a tabletop
sweetener. Like all intense sweeteners it is virtually calorie free and does not affect blood glucose levels.
Recent media reports have questioned the safety of aspartame linking it to a wide range of serious medical
conditions. Diabetes UK takes seriously any reports about the safety of products, which may be of particular interest to people with diabetes.
The UK government along with many international experts regularly review the safety of foodstuffs and currently believe that there is no evidence
to support any of the questions being raised in relation to the safety of aspartame. Diabetes UK will continue to monitor this
situation
Diabetes UK suggests that if you do use intense sweeteners or products sweetened with them, then you should choose a variety so as to reduce the
risk of exceeding the Acceptable Daily Intake (ADI) for each one.
Diabetes UK produces a Sweetener Guide that provides further information on the use of sugar and sweeteners. For details on how to order a copy
go to: Catalogue.
(Please note: people with the condition Phenylketonuria are unable to metabolise the amino acid phenylalanine that is found in aspartame. They
should avoid aspartame for this reason.)
Welfare benefits
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People with diabetes are not entitled to benefits or tax credits just because they have diabetes. Some benefits are general and available to
all, other benefits and tax credits are available for people who need additional help or care. For someone with diabetes this might be for the
care needed for the disabling effects of complications such as blindness, or for parents whose children have diabetes and they need additional
supervision or assistance because of their diabetes.
People with diabetes, who are treated with any type of medication, are entitled, to free prescriptions and NHS sight tests. Leaflets about this
and other benefits are produced by the Benefits Agency. For information about free prescriptions see their leaflet HC11 Are you entitled to help
with health costs?
Where to get advice and information
Information on benefits and tax credits is available in the benefits and services A-Z listing on the Department for Work and Pension’s website
and on the Entitled to™ website. (Diabetes UK is not responsible for the content of external websites.)
Your local Citizen’s Advice Bureau and Welfare Rights Officers (for appeals) can check whether you are getting all the benefits to which you are
entitled to. Visit the National Association of Citizen’s Advice Bureaux’s website to find out details of your local bureau. (Diabetes UK is not
responsible for the content of external websites.)
The Community Legal Service should also be able to provide you with free advice services and details of organisations in your area. They can be
contacted on 0845 608 1122.
You may also be able to find information at your local library, and the librarians should be able to assist you locate the information you need,
eg the Disability Rights Handbook published by the Disability Alliance. This is useful for information about disability benefits and the kind of
information to include in an application. The phone numbers for local agencies can be found in the telephone directory, eg Benefits Agency.
Housing and Council Tax Benefit, information should be available from your local council. Leaflet MG1 A guide to benefits is available from
social security offices. Information about benefit rates is contained in the leaflet GL23 Benefit rates, which is updated every year. In general
you should apply as quickly as possible as you may lose money if you do not.
If your first language is not English, then information should be available in your own language, and an interpreter can be made available if you
need it for interviews. You can also get help to complete the forms. Local voluntary organisations may also be able to help with advice and
information, and even if they do not know themselves can often refer people to the right place.
Infant diets and Type 1 diabetes
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We do not know the causes of Type 1 diabetes. Recent research funded by Diabetes UK has brought us closer to understanding the genetic basis of
Type 1, however we are still a long way from identifying the environmental factor(s) that trigger the disease in susceptible individuals.
Much attention has been given to the idea that the source of infant nutrition, breastmilk versus infant formula is associated with the risk of
developing Type 1 diabetes.
Attention has been directed at the cow’s milk hypothesis. Evidence supporting this includes reports that people who were not breastfed or were
breastfed for only a short time, are at increased risk of Type 1, that the frequency of disease in animal models of Type 1 can be modified by
alteration of cow’s milk components to animal feed, and that up to 100 per cent of newly diagnosed Type 1 diabetic patients have antibodies to
bovine serum albumin (BSA). These three lines of evidence have been joined in a hypothesis that the autoimmune features of Type 1 are triggered
by consumption of infant formulas based on cow’s milk too early in life, by individuals genetically predisposed to Type 1.
To date studies involving infant diets investigating the above hypothesis have given conflicting results. A combined analysis of 11 studies
comparing the feeding practices of people developing Type 1 diabetes versus non diabetics, identified a weak but significant association between
infant nutrition and Type 1. Two studies from the UK, Leicester and Belfast, have not supported this notion. Studies of cow’s milk consumption
per person in relation to incidence of Type 1 in various geographical regions, showed a positive correlation, but they were based on populations
and may not be relevant to individual cases of Type 1. Studies of other environmental agents have postulated numerous other associations, ie
sugar consumption, caffeine/coffee intake, geographical latitude or temperature. No strong support for the cow’s milk hypothesis can be given by
infant feeding practices or by global dietary studies, because there are several concerns over the accuracy and applicability of their
message.
The true answer to this question will necessitate greatly expanded and properly designed trials. However, variety and complexity of food
constituents, the timing and quantity in which they are consumed and the potential for interaction with other environmental agents make
identification of triggers resulting in the development of Type 1 diabetes very difficult. Dietary studies should be broadened beyond cow’s milk
to identify other potential chemical, plant and animal agents. The absence of data to support the hypothesis should preclude large trials aimed
at preventing Type 1 through cow’s milk avoidance.
Although breastfeeding is worth encouraging for many reasons, current infant feeding practices should not be changed with the aim of avoiding
Type 1, until stronger evidence is available on the role of foods in precipitating Type 1diabetes
Kidney disease - some common questions
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Q. How many people get kidney disease?
A. Kidney disease can happen to anyone but it is much more common in people with diabetes and people with high blood pressure. Kidney disease in
diabetes develops very slowly, over many years. It is most common in people who have had the condition for over 20 years. About one in four
people with diabetes might go on to develop kidney disease, though, as treatments improve, fewer people are affected.
Q. Why are people with diabetes more at risk?
A. As with many of the other complications of diabetes, kidney disease (or nephropathy to give it its proper name) is caused by damage to small
blood vessels. This damage can cause the vessels to become leaky or, in some cases, to stop working, making the kidneys work less efficiently. It
is now known that keeping blood glucose levels as near normal as possible (between 4 and 8 mmol/l) can greatly reduce the risks of developing
kidney disease as well as other diabetes complications.
Q. So, what actually happens if I have kidney disease?
A. The kidneys are the organs which filter and clean the blood and get rid of any waste products by making urine. They regulate the amount of
fluid and various salts in the body, which helps to control blood pressure. They also release several hormones.
If the kidneys start to fail, they can no longer carry out any of these activities as well as before. In the early stages of disease, it may mean
that there are changes in blood pressure and the fluid balance of the body. This can lead to swelling, especially in the feet and ankles. As the
disease progresses, the kidneys become less efficient and the person can become very ill. This generally happens as a result of the build up of
waste products in the blood, which the body cannot get rid of. It can be a very serious condition, which is why it is very important to detect it
at its earliest stage.
Q. Is that why they test my urine at the hospital?
A. Yes. Everyone with diabetes should have at least an annual check up, which should include a urine test for protein. One of these tests looks
for tiny particles of protein in the urine, called 'microalbuminuria'. These appear during the first stages of kidney disease, as the kidneys
become 'leaky' and lose protein. At this stage the kidney disease can often be treated successfully, so this test is very important.
Q. I had protein in my urine but now the test is negative. How can that happen?
A. Kidney disease is not the only reason for protein to appear in the urine. If you have a urinary tract infection (UTI) this can lead to protein
being passed out in the urine. People with poorly controlled diabetes can be more prone to this type of infection. This is because the glucose,
in the urine, provides a perfect breeding ground for bacteria. This might need treatment with antibiotics. In some cases, if the infection
persists, it can cause some damage to the kidneys, so it is very important for people with diabetes to visit their doctor if they develop a
urinary tract infection.
Q. I had a positive test for protein and now the doctor wants me to do a '24 hour urine save'. Why is this?
A. If you have had a positive test for microalbuminuria at the clinic, the doctor might want to see how much protein you are actually losing
through your kidneys. This will help him/her assess how well your kidneys are still working. A 24 hour urine test does precisely that. You will
be given a large bottle and must save every specimen of urine that you pass in a 24 hour period. This is then sent to a lab and analysed and the
results show how much protein you are losing in a day.
Q. What sort of treatment might they recommend?
A. This very much depends on the individual patient, the type of diabetes and other factors, such as blood pressure. Keeping blood pressure low
is extremely important and tablets for lowering blood pressure are often used.
An increasingly common form of treatment, especially for people with Type 1 diabetes and normal or raised blood pressure, is 'ACE inhibitor'
drugs. These are also successful in people with Type 2 diabetes who have high blood pressure, as they not only protect the kidneys but they also
lower the blood pressure. They may also help people with Type 2 diabetes and normal blood pressure, but this has not yet been proved.
Your doctor should discuss any treatment with you before starting you on it, explaining what it does and how it will help.
Q. What if the kidney disease gets worse?
A. There are many ways of treating kidney disease, if the kidneys are no longer able to function properly. You may need to limit certain foods in
your diet, such as protein foods or foods high in potassium phosphate or sodium. This aims to prevent waste products building up in your
body.
As there may be a number of different things to consider, the diet can be quite complicated to follow. If you need to make any changes to your
diet, you should receive detailed advice from a state registered dietitian.
Controlling blood pressure is also very important. If the kidneys have been damaged, the filtering and cleaning of the blood cannot be done
normally. In some cases, dialysis might be needed to do this job for the kidneys. There are various types of dialysis and your doctor will decide
which is the best one for you.
Q. Who can I contact for more information about this?
A. In the first place, it is sensible to talk with your diabetes team. They should be able to answer most of your questions about kidney disease
and the treatments available. If you would like some more information, especially about the later stages of kidney disease, the National Kidney
Federation produces leaflets on this topic and can put you in touch with a local group.
Kidney problems with diabetes?
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ACE inhibitors
ACE Inhibitors (angiotensin-converting enzyme inhibitors) are drugs used commonly in the treatment of high blood pressure. They work by blocking
the action of a chemical called an angiotensin converting enzyme. This enzyme is responsible for controlling blood pressure. It does this by
making the blood vessels in the body, the veins and arteries, constrict. This makes it harder for the blood to flow through them and so it
increases blood pressure. By stopping this enzyme working, ACE inhibitors reduce the constriction of the blood vessels. This reduces the blood
pressure.
High blood pressure (hypertension) is often associated with diabetes and it poses a greater threat to people with diabetes than it does to people
without diabetes. This is because high blood pressure is one of the major factors influencing nephropathy (damage to the kidneys) and people with
diabetes are already at a greater risk of developing nephropathy. High blood pressure is also associated with eye and cardiovascular disease,
which are also high risk areas for people with diabetes.
Controlling high blood pressure is, therefore, very important in people with diabetes, to reduce the risk of developing complications. Even if
nephropathy has started to develop, controlling blood pressure can substantially slow its progression. To try and prevent such damaging effects,
the lower blood pressure reading (the diastolic) should normally be kept under 90 mmHg, although this will vary with age.
ACE Inhibitors have been shown not only to control blood pressure but also to delay the onset and the progression of nephropathy. In fact this
ability to protect the kidneys from damage seems to be their most important quality, more so than their ability to actually control blood
pressure. They are as effective as other tablets in controlling blood pressure but have the added benefit of protecting the kidneys.
ACE Inhibitors also have no adverse effects on the rates at which carbohydrate is broken down and used, unlike some other medicines. For people
with insulin dependent diabetes, small doses can be given which protect the kidneys without drastically lowering the blood pressure, which means
that they can be given to people who do not have high blood pressure but are showing signs of kidney damage. This may also prevent increases in
blood pressure in the future. This effect has not been seen in people with non-insulin dependent diabetes but the fact that ACE Inhibitors do not
affect insulin resistance makes them a useful way of controlling blood pressure for this group of people.
Kidney damage can be diagnosed by testing for the presence of protein in the urine (microalbuminuria). This is an indication that kidney damage
has started and this is why people with diabetes should have their urine checked at least once a year. At this stage the kidney damage is
treatable but, if it goes unchecked, it can get worse and lead to serious complications. ACE inhibitors might be used at this stage, even if the
person is already on another type of medicine for high blood pressure.
Drugs of this type include Captopril, Enalapril, Lisinopril, Perindopril and Ramipril amongst others. All need to be started very carefully, in
small doses and then increased to achieve the best effect for the individual. The doctor should then monitor the blood pressure and urine three
to six monthly to ensure there is no kidney damage and may wish to carry out some blood tests, in the early stages of treatment, to make sure
that kidney problems are not exacerbated and potassium levels remain satisfactory.
ACE Inhibitors should be avoided during pregnancy and in people who have already developed renovascular disease (damage to the blood vessels
supplying the kidneys). Possible side-effects are; a persistent dry cough; low blood pressure with dizziness and headaches; nausea and diarrhoea
- though not all patients will experience these.
March 1996
Restaurants & Eating out coping with diabetes
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Q. We enjoy eating out regularly with our family and our youngest son, who has diabetes, injects his insulin discreetly at the table before
his meal. We have been asked by the restaurant that we visit regularly, if we would mind sitting at a table that is more secluded because of
this. Our son is not embarrassed and is upset that he should be hidden away. Can the restaurant insist we sit in a more secluded position?
A. If the restaurant have asked you to sit out of view of other customers so that they do not see your son inject his insulin, it is acting
unlawfully. Your son is being treated less favourably because of his diabetes.
Insulin Pumps
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For info about insulin pumps click here for minimed
http://www.minimed.com/patientfam/pf_ipt_ptov_whygoodcontrol.shtml
This link takes you to insulin pump faq's ( frequently asked questions ) again
at the minimed site
Islets cell transplantation FAQ's
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Q. Where do the islets come from that are used in islet cell transplantations?
A. The islets come from people classified as being clinically brain-dead (ie they no longer showed any brain activity).
Q. Can you use stem cells to create islets in the future?
A. On Monday 22 January, the House of Lords voted to amend the Human Fertilisation and Embryology Act to allow embryonic stem cell research to be
carried out for chronic conditions and diseases. The new regulations will come into effect on 31 January 2001 and applications for research
licences to carry out research using embryonic stem cells can be submitted after that date. The government and House of Lords Select Committee,
along with organisations such as Diabetes UK involved in medical research, are acutely aware of the ethical concerns and considerations that
accompany embryonic stem cell research. Diabetes (including islet cell transplantations) could potentially benefit from embryonic stem cell
research, and Diabetes UK would have to take any research application using such cells to its Board of Trustees for consideration, if or when
such an application was received.
Diabetes UK is aware of the benefits embryonic stem cells could bring to people with diabetes, but is also aware that some of its supporters and
members are ethically opposed to such research. Diabetes UK promises to enable people donating money to diabetes research to spend their money
only on research that does not involve embryonic stem cells, whenever such a request is made.
Q. Can I donate my islets for transplantation?
A. No, it is not possible to take islets from living donors. The pancreas is a fragile structure that could easily be destroyed by the extraction
of islets. Also, people who have islet cells that work, need to keep them for all their lives, or for as long as they continue to work properly.
Otherwise they run the risk of developing diabetes themselves
Q. Can I donate my pancreas for transplantation or for islet removal?
A. Again, it is not possible to take islets from living donors (see previous question). Removal of the pancreas could easily damage it making it
unsuitable for transplantation. Also, removal of the pancreas from someone who does not have diabetes would result in them developing diabetes
themselves. People who have diabetes already have either no islets or islets that are not functioning properly. Unfortunately, therefore, their
pancreases and/or islet cells would not be suitable for organ or tissue donation
Q. Is islet cell transplantation a cure for diabetes?
A. It is too soon to say whether islet cell transplantation is a cure for diabetes. Thirteen out of 15 islet cell transplantations done so far in
Edmonton, Canada, have been 100 per cent successful. However, until patients have lived with the transplants for a number of years, we will not
be able to say definitively whether islet cell transplantations are a cure for Type 1 diabetes. Even then, there will always be a risk of
transplant rejection and side effects of having to take long-term immunosuppression drugs.
A real cure would mean that transplants were suitable for all people with diabetes, using less islets, were all 100 per cent successful, and
didn’t need any immunosuppression drugs to prevent rejection.
Q. What are the side effects of the immunosuppression drugs used so far in the Canadian research?
A. Some people got mouth ulcers but these disappeared when the dose of one drug (Sirolimus/Rapamune) was lowered and used in tablet form instead
of a liquid form. Two of the transplantees have experienced deterioration to their kidney function. Whilst this has not resulted in anyone
needing kidney transplants, the progress of these individuals is being carefully monitored as they had very poor kidney function prior to their
transplants. Four transplantees have experienced a rise in their blood lipid levels, a side effect of Sirolimus. This could be dangerous for
people with diabetes who have damaged blood vessels prior to a transplant, as the high lipid levels could, for example, raise blood pressure
and/or cause strokes. However, in people who do not have damaged blood vessels, Sirolimus has been shown to prevent inflammation and
atherosclerosis (‘furring of the arteries’). A rise in blood lipid levels can be controlled when necessary in the transplantees.
One brief news article reported that Sirolimus caused a rare type of pneumonia (interstitial pneumonia) in people taking the drug. However, that
sort of complication can occur with many different drugs. It is important to remember that no drug is 100 per cent safe, and every drug has side
effects. This is one of the rarer side effects of Sirolimus, an immunosuppressant drug widely used in kidney and liver transplants all over the
world; so rare that out of the many thousands of people who have been treated with the drug, it is only now that a report has appeared in the
press about it.
Q. Why have two of the islet transplantations not worked?
A. The islet transplantations have not completely failed in these two individuals – they need to take only about one fifth of the insulin they
were injecting before their transplants. One transplantee is showing signs of insulin resistance (a good reason to continue research into the
mechanisms behind insulin resistance), and around half the islets in the other transplantee do not seem to be working. These transplantees may
need a further islet cell transplant in the future. The exact reasons for the insulin resistance and failure to work of islets is not understood
at the moment. It will be interesting to see whether a further transplant will get rid of these problems.
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Q. Is islet cell transplantation right for everyone with diabetes?
A. At the moment islet cell transplantation is only suitable for people with Type 1 diabetes who have extreme problems in controlling their blood
glucose levels, despite sticking very carefully to intensive insulin treatment regimens. People who receive islet cell transplantations spend the
rest of their lives on a cocktail of drugs to prevent the body rejecting the new cells (immunosuppression). The long-term effects of taking these
drugs are not yet known, but could be very damaging. Hence, the health risks from the drugs currently outweigh the benefits of islet cell
transplantations for most people with diabetes. At the moment people with Type 2 diabetes are not being considered for the islet cell
transplantation research. However, that is not to say that in years to come this won’t change, especially when more information will be known as
a result of current research. In the meantime, considerable funds are being ploughed into researching the mechanisms behind insulin resistance, a
characteristic of Type 2 diabetes. Such research could hold the key to a future cure for Type 2 diabetes.
Islet cell transplantation research is by no means the only research area Diabetes UK funds. Indeed, the £4.5 million diabetes research we fund
each year is so important to us, that rather than drop existing projects to pay for islet cell research, we have chosen to raise extra money
instead – ensuring we do not jeopardise existing research, developments, and, hopefully, breakthroughs. Research into Type 1 and Type 2 diabetes
is often related, and the results of one project may easily benefit the knowledge and techniques used in other projects, speeding up the overall
research process and delivery of results that benefit people with diabetes in their everyday lives. This means that all donations contribute to
our overall understanding of diabetes and the chances of one day finding a cure.
Q. Can my child have an islet cell transplant?
A. At the moment islet cell transplants carried out using the Canadian research method are not suitable for children who have diabetes. This is
because researchers are not sure about the long-term side-effects of the immunosuppressant drugs used to prevent rejection of the transplant.
These drugs may be extremely toxic (even cancerous) and we need to eliminate as many of the health risks associated with islet cell
transplantation as possible, before going ahead with a transplant in a child.
Q. How can I take part in the islet cell transplant research and/or get onto a waiting list for an islet cell
transplant?
A. The Consortium is now looking for volunteers who match the patient selection criteria – people with Type 1 diabetes aged between 18
and 65, whose insulin and healthy diet regimen are failing to control their blood glucose levels despite their best efforts, often causing severe
hypos. People with Type 1 diabetes who have kidney disease, insulin resistance or have had repeated episodes of DKA (diabetic ketoacidosis) will
not be able to take part.
People with diabetes cannot put themselves forward as volunteers – this can only be done by a healthcare professional who is part of your
diabetes care team. If you think you match the patient selection criteria then you should discuss this with your diabetes care team.
Diabetes UK appreciates that there will be many people with diabetes who would like to take part in an islet cell transplantation research
programme. However, the actual number of people selected to take part is likely to be extremely small – only 10 people will receive islet
transplants in the UK by the end of 2002. There are around two million people with diabetes in Canada (around 10 per cent with Type 1 diabetes
and around 90 per cent with Type 2), but only 15 people have so far been selected to take part in Shapiro and Lakey’s clinical study. It will not
be possible to ‘buy’ a place in the research programme.
Q. Can I ‘buy’ a place on an islet transplantation waiting list?
A. It will not be possible to ‘buy’ a place on an islet transplantation waiting list. All potential transplantees will be selected according to
the patient selection criteria. Individuals will not be expected to pay for the transplantation, therefore, a person’s ability to pay for a
transplant will not affect their selection to take part in the research project. Individuals will not be able to put themselves forward for the
research project – this can only be done by a healthcare professional in your diabetes care team.
Healthcare professionals will discuss the research with individuals whom they think fit the criteria.
There will be very strict rules that the researchers taking part in the study will have to follow when selecting people to take part in the
research programme. Therefore, very few people will be able to take part in the initial research. The selection process will balance the risks to
people who may undergo an islet transplantation with the benefits they could receive.
Q. How much will the research programme in the UK cost?
A. Whilst it is not possible to ‘buy’ a place in the research programme, Diabetes UK needs a lot of financial support to allow the research to go
ahead. All diabetes research is important, and we don’t want to stop funding any of our current projects in order to follow only this one area of
interest. Therefore, in order for us to get the technology, staff and expertise needed to work on islet cell transplantation in the UK, we need
to raise as much money as possible, as soon as possible. If we don’t have the money, the research project won’t go ahead, and the likelihood of
islet cell transplantation ever being successfully carried out in the UK will be many, many years away.
The initial pilot phase will cost over £300,000. The eventual cost is difficult to determine, but may potentially cost millions more.
Q. Once islet cell transplantation is ready to be taken forward, how many people will be treated in the UK?
A. It is not possible to say how many people will utimately be treated by islet cell transplantations in the UK. There are currently around 800
pancreases available through organ donations every year in the UK, and about 25 of those are suitable for whole pancreas transplants. Each islet
cell transplantation needs, on average, islets from two donor pancreases for the transplantation to be successful. Therefore, in theory, it would
be possible to treat up to 400 patients with islet cell transplantations every year. However, this is only a very rough estimate, and it assumes
that each islet cell purification procedure (when islet cells are removed from donor pancreases for transplantation) is successful. At the moment
this procedure is not 100 per cent efficient and researchers are still investigating ways of standardizing how many islet cells are recovered
from each purification.
Transplant progress in the UK
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Following the announcement of James Shapiro’s successful islet cell transplantations in June, Diabetes UK formed the Diabetes UK Islet
Transplantation Consortium (Diabetes UKITC) – made up of medical researchers interested and/or involved in islet cell research in the UK.
The Consortium has been looking at ways to take islet cell transplantation forward and have identified the scientific, surgical and technical
expertise required by UK professionals to become involved in this research, as well as the formidable costs.
Plans are already in place to develop facilities for islet transplantation at:
University Hospitals of Leicester
King’s College Hospital, London
Royal Free Hospital, London
Worcestershire Acute Hospital NHS Trust
Southmead Hospital, Bristol
Addenbrooke’s Hospital in Cambridge, and the
John Radcliffe Hospital, Oxford.
If all goes well, the Consortium hopes to perform 10 islet transplants in the UK within a year of getting the first facilities up and running.
However, the availability of islets is very limited and the treatment remains experimental.
The Consortium are now looking for volunteers who match the patient selection criteria – people with Type 1 diabetes, aged between 18 and 65,
whose insulin and healthy diet regimen are failing to control their blood glucose levels despite their best efforts, often causing severe
hypos.
Diabetes UK is not involved in the selection of volunteers for this research project. People with diabetes cannot put themselves forward as
volunteers – this can only be done by a healthcare professional from your diabetes team. If people think they match the criteria they should
discuss this with their diabetes care team.
Costs
The initial pilot phase of the UK islet transplantation initiative will cost over £1/4 million. This money will be spent on replicating the
Edmonton protocol at the University Hospitals of Leicester and for equipping the other research centres to investigate techniques associated with
islet cell transplantation. The University Hospitals of Leicester plans to have the appropriate facilities in place to begin clinical
transplantations by Spring 2001.
It is hoped that the UK islet research initiative will be able to reproduce and develop the Edmonton protocol successfully. The researchers face
many challenges and will rely on Diabetes UK’s fundraising abilities to get their work off the ground. If the work of the pilot phase is
successful, considerably more funding will be required to develop new protocols that will make the procedure more widely available.
The ‘Edmonton’ Protocol
The ‘Edmonton’ protocol is a new procedure developed in Canada for transplanting healthy islet cells into people with Type 1 diabetes.
The series of islet transplantations carried out by James Shapiro and his team since March 1999 has enjoyed levels of success that are
unprecedented in the field of islet transplantation surgery. Since the Edmonton transplantation research trial began, 13 of the 15 patients who
have received islet cells using the new procedure are still free from the need to inject insulin. Previous islet cell transplants have only
succeeded in around eight per cent of cases.
One of Mr Shapiro’s success stories has been Canadian lawyer Bob Teskey, who no longer needs to inject insulin. In the article Bob's hope, Bob
describes how he got involved with the ‘Edmonton’ protocol and how it has affected his life.
The islet transplantations undertaken in Canada have so far been carried out on people like Bob – who’s blood glucose levels could not be
controlled by insulin therapy. They took part because the risks of transplants and the immunosuppression that goes with islet transplantations
were considered to be less than the risks of continued poor blood glucose control and the poor quality of life that went with it.
Poorly controlled blood glucose levels can lead to diabetic complications such as heart disease, strokes, amputations, blindness and kidney
failure.
What happens during the ‘Edmonton’ protocol?
The ‘Edmonton’ protocol does not involve major surgery. The transplants are carried out under local anaesthetic in the x-ray department of a
hospital. A very thin needle is used, along with x-rays, to locate the main blood vessel in the liver (the portal vein), into which the
blood-type-matched islet cells are injected. Once into the liver the islet cells develop a blood supply and begin producing insulin.
The majority of the Canadian transplantees received two transplants over an average of 29 days and, at most, only needed to stay in hospital for
a day or two.
Why transplant islets into the liver?
Research into other islet transplantation protocols has shown that the most successful transplantations occur when the liver is used as a home
for the transplanted cells. The liver is able to regenerate itself when damaged, building new blood vessels and supporting tissue. Therefore,
when islets cells are transplanted into the liver, new blood vessels form around them so that the insulin they produce can easily get into the
blood stream and be carried around the body helping to control blood glucose levels.
Why has the ‘Edmonton’ protocol been successful?
The success of the ‘Edmonton’ protocol has been attributed to a number of factors. Patients receive a new combination of drugs to prevent the
body from rejecting the transplanted islets. This dispenses with the steriods used in previous islet transplants, which could damage the new
islets and induce insulin resistence. The transplantees also receive islets from the equivalent of two donated pancreas, a far higher number of
islets than has been transplanted in the past.
The work of Mr Shapiro is undoubtedly exciting and Diabetes UK welcomes the news of its success so far. Further research still needs to be done
into this procedure, and Diabetes UK is helping to coordinate the UK islet research initiative, which aims to both replicate and develop the
transplantation success seen in Canada.
Mr Shapiro has published one research paper on his work, ‘Islet transplantation in seven patients with Type 1 diabetes mellitus using a
glucocorticoid-free immunosuppressive regimen’, in the New England Journal of Medicine (July 2000). This paper can be found on the New England
Journal of Medicine’s webiste: http://www.nejm.org/
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