Archive for the ‘trials’ Category
Monday, August 25th, 2008
BCG stand for the Bacillus Calmette-Guérin, which was developed by two French scientists called Albert Calmette and Camille Guérin. After much development it was introduced in 1921 and has been used extensively as a vaccine against tuberculosis.
It seems to have a number of interesting effects on the immune system which mark it out as rather different from other vaccines. It has been used to prevent a number of other diseases, and can be of value in bladder cancer. There is now evidence that it may have a place in the treatment of some people with Type 1 diabetes.
Trials have used BCG to kill the immune cells that are responsible for destroying the insulin producing cells in the pancreas, which leads to Type 1 diabetes. Studies using mice have shown that a similar treatment results in a permanent cure for about a third animals treated in this way.
This is still a long way away from this to direct application to humans and this approach will probably be successful in only a minority of cases, but it does represent another interesting development.
Read more at www.diabetescurereview.com/BCG-vaccine.html
And don’t forget to take a look at my main website at www.DiabetesDietDoctor.com.
Tags: BCG, cure, diabetes, treatment, Type 1, vaccine
Posted in Type 1, cure, diabetes, studies, study, trials | No Comments »
Sunday, July 6th, 2008
Yes folks, I’ve now launched the membership site, with information, a community forum and structured learning programmes for people with diabetes and their families.
Check it out right now at www.diabetesdietdoctor.com.
Tags: blood glucose, blood glucose control, blood sugar, blood sugar control, control, daibetes, diabetes, diabetes control, diabetes diet, diabetes diet doctor, diabetes diet plan, diabetes doctor, diabetes education, diabetes food, diabetes help, diabetes information, diabetic diet, diabetic diet plan, diabetic doctor, diet, food, glucose, lose weight, lose wieght, obesity, sugar, Type 1, type 1 diabetes, Type 2, type 2 diabetes, Type1, Type2, weight loss, wieght loss
Posted in Type 1, Type 2, diabetes, diet, genes, genetics, glucose control, obesity, review, studies, study, trials, weight control | No Comments »
Thursday, April 24th, 2008
One of the conclusions reached from The Efficacy of Self-MONitoring in newly diagnosed Type 2 diabetes (ESMON) study recently published online by the British Medical Journal (BMJ) was that the group allocated to more intensive self monitoring scored significantly higher for depression than the control group. This has also been found in other studies of self monitoring.
Well, maybe so, but in this study, just as in all the others, the approach to self monitoring was such that no real improvements in control were achieved. It’s no good getting people to do the tests without putting the appropriate amount of effort into making sure that they know what to do with the results. In this study, the triallists did give some thought to this, but still certainly not enough.
Because of this, there was no overall improvement in control as assessed by the HbA1C levels. My guess is that the patients were just disappointed in their lack of improvement. And I don’t blame them.
Self monitoring, putting the patients in real control of their condition, has the potential to transform their lives by giving them confidence and hope, and offering real benefits in terms of preventing or even reversing the progress of their condition. Some people figure out how to do it on their own. An awful lot more could do it if properly trained.
BMJ, doi: 10.1136/bmj.39534.571644.BE (published 17 April 2008)
Tags: control, depression, diabetes, glucose, glucose control, HbA1c, minitoring, self monitoring, Type 2, type 2 diabetes
Posted in Type 2, diabetes, glucose control, studies, study, trials | No Comments »
Tuesday, April 22nd, 2008
Yet another review (and papers in the same edition of the British Medical Journal) saying that self-monitoring in Type 2 diabetes is a waste of time and resources.
The review is by a Public Health doctor who summarises the “evidence” he has found by reading the papers and following their reference links. The papers show that in controlled trials, there is no benefit for self monitoring in terms of falls in HbA1C concentrations when compared with patients who were managed without taking their own blood glucose measurements.
This is not surprising because the HbA1c levels were not high in the first place, so any change could only be marginal.
In addition, in common with all other studies of this type, the approach to self monitoring was that only small changes were made to the tablets or to diet in response to the results of relatively few measurements.
Self monitoring is a potential life-saver in Type 2 diabetes when used intelligently. What is required is a period of intensive monitoring so that the person with diabetes learns exactly the effect of different amounts of different foods on their blood glucose levels and how to keep their fluctuations in blood glucose to a minimum. After this period, much less testing is needed because they know how and when to eat.
The complications of diabetes cost healthcare systems a huge amount of money, and this will go on increasing until people with diabetes take charge of their own condition and (mainly through reducing carbohydrate intake) get it under good control. Self monitoring is an essential part of that process, but education about what to do with the results is the key. Unfortunately, most diabetes professionals don’t seem to have grasped this yet.
The waste of time and resources is in doing these studies and publishing the results.
Read if you want, but don’t get discouraged.
And do go on testing, so you can learn how to improve your control.
Research, doi: ; doi: 10.1136/bmj.39526.674873.BE 10.1136/bmj.39534.571644.BE
http://www.bmj.com/cgi/content/abstract/bmj.39534.571644.BEv1
Tags: blood glucose control, complications, control, diabetes, glucose control, intensive control, monitoring, self monitoring, Type2
Posted in Type 2, diabetes, glucose control, review, studies, study, trials | No Comments »
Sunday, April 6th, 2008
In an international study of 839 obese patients with Type 2 diabetes, rimonabant produced significant wieght loss, a reduction in waist size and an increase in HDL (”good”) cholesterol levels, but did not lead to any significant change in percentage atheroma volume. There was a small effect on total atheroma volume, but this was not clinically significant. The drug was associated with a high level of psychiatric side effects, as it has done in previous trials, and it has now been withdrawn in the US for this reason.
Weight loss in diabetes remains problematic, but the answer still seems to lie in cutting energy intake, particularly of carbohydrates, and taking more exercise.
Nissen et al. JAMA. 2008;299(13):1547-1560. Published online April 1, 2008 (doi:10.1001/jama.299.13.1547).
Tags: atheroma, atherosclerosis, diabetes, glucose, heart disease, rimonabant, study, trial, Type 2, waist circumference, weight control, weight loss
Posted in Type 2, diabetes, trials, weight control | No Comments »
Sunday, April 6th, 2008
A Study published recently in the Journal of the American Medical Association in patients with type 2 diabetes and coronary artery disease, treatment with Actos (pioglitazone) resulted in a significantly lower rate of progression of coronary atherosclerosis compared with glimepiride. The changes were small, however, and the variability of the results wide.
The results have been challenged by other researchers, and although this is interesting, it does not seem to me that this is likely to represent any sort of breakthrough. The studies are continuing though, and may help us understand the mechanisms of heart disease in diabetes rather better.
Nissen et al. JAMA. 2008;299(13):1561-1573. Published online March 31, 2008 (doi:10.1001/jama.299.13.1561).
Tags: actos, atheroma, atherosclerosis, diabetes, glucose, heart disease, periscope, pioglitazone, study, trial, Type 2
Posted in Type 2, diabetes, glucose control, trials | No Comments »
Tuesday, March 18th, 2008
Following the recent stopping of the Intensive control arm of the ACCORD study of patients with Type 2 diabetes because of an excess of deaths in this group, the investigators in the Australian ADVANCE study ran a preliminary analysis of their data, and found no increase in deaths in their Intensive control patients. This will come as a relief to any of you who were worried that tight control might actually be bad for you. There are some differences between the studies - the ADVANCE patients did not already have the same degree of cardiovascular risk factors as those in ACCORD, and the US patients were even more intensively treated with insulin.
So the message as far as I’m concerned still is - go for good control.
TW
Tags: complications, control, death, diabetes, glucose, glucose control, insulin, intensive glucose control, study, trial, trials, Type 2
Posted in Type 2, diabetes, glucose control, trials | No Comments »
Thursday, March 13th, 2008
I just came across a very interesting report in the Journal of the American Medical Association (JAMA) from January this year. This was a controlled trial of surgery (gastric banding) comared with conventional weight loss treatments in obese people with Type 2 diabetes.
The conventionally treated group lost less than 2% of their weight on average, although there was some improvement in their diabetes in those who lost more than 10%. The surgical group lost an average of more than 20% of their weight over the 2 year study period, and a stunning 73% of them had complete remission of their diabetes, with no serious complications of the surgery.
Strong evidence indeed that weight loss is the key to improving control in Type 2 diabetes, although it is disappointing that the results in the diet alone group were so poor and that they lost so little weight. The diet, however, was the usual “balanced” diet still usually recommended by dieticians for wieght loss, and I wonder what would have happenned if a low carbohydrate approach had been used. We can’t use gastric banding on everybody!
The reference is Dixon et al. JAMA Jan 23, 2008. Vol 299 No3. 316-323.
Tags: cure, diabetes, diet, obesity, overweight, surgery, Type 2, weight
Posted in Type 2, diabetes, glucose control, trials | 2 Comments »
Sunday, February 17th, 2008
If anyone was getting depressed about the ACCORD results, they can take heart from another large study from Steno in Denmark, just published in the New England Journal of Medicine, in which lowering of the blood sugar and HbA1c levels resulted in an almost 50% fall in overall death rate, particularly from heart disease. Many fewer patients progressed to end-stage kidney failure or required laser treatment to their eyes. Major side effects were rare.
You can find the abstract at: http://content.nejm.org/cgi/content/short/358/6/580?query=TOC
Other large studies from both sides of the Atlantic have reported broadly similar results.
We’ll have to wait and see what comes out of the discussion of the ACCORD results, but it is clear that nobody should panic about this or change their treatments right now.
TW
Tags: blood glucose control, complications, control, diabetes, glucose control, intensive control, Type2
Posted in Type 2, diabetes, glucose control, trials | No Comments »
Monday, February 11th, 2008
You will no doubt be seeing in the newspapers in the next few days that one part of the huge ACCORD trial in patients with Type 2 diabetes has been stopped because of an increased death rate in the group of people assigned to intensive blood glucose control. This is a great shock and no doubt will be taken by some people to indicate that good control of blood glucose may be a bad thing.
No single drug or set of drugs could be identified as being responsible for this, but it all the people in this group were receiving multiple treatments for the diabetes and many of them were using insulin as well as tablets. They did seem to have better blood glucose control in that the haemoglobin A1c levels were significantly lower than in the standard treatment group, but despite this more of them died during thestudy period than in the standard treatment group.
As ever, these results need to be viewed with some care. The group of people included in the study not only had had diabetes for an average of 10 years and were relatively old, but they also had poor control and known heart disease or at least two other risk factors. Although their death rate appeared to be higher in the intensive control group, the rate of non-fatal heart attacks was actually lower and there was no consistent cause of the excess of deaths.
Previous studies have suggested that lifestyle measures leading to better blood glucose control can slow the progress of the condition and reverse some of the complications so this result really does come as a surprise.
The first thing to say is that the results may be a statistical anomaly, which are not that uncommon in large trials of this type (remember the HRT trials?). The second is that it is not the lower blood glucose levels that are likely to be causing the deaths, but rather the treatments. Modern views of diabetes care (not yet promoted by either the American Diabetes Association or Diabetes UK) might say that most of the treatments, and particularly insulin in Type 2 diabetes may well cause more problems than they cure.
You will find a good discussion at: http://www.healthcentral.com/diabetes/c/5068/20145/study-whats/1/
If you want to look at the detail and see what the ACCORD study is all about you can find it at http ://www.nhlbi.nih.gov/health/prof/heart/other/accord/index.htm.
In the meanwhile DON’T CHANGE YOUR TREATMENT! Good glucose control matters.
Tony Woolfson
Tags: ACCORD, blood glucose, complications, control, death, diabetes, insulin, study, trial, Type 2
Posted in Type 2, diabetes, glucose control, trials | 1 Comment »