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Posts with tag islet.org

The specials tonight are fulminant and non- fulminant

A type 1 diabetic mystery is why do some Type 1s get complications and others seem to never get them? A massive Japanese study of Type 1 diabetics found that those with fulminant diabetes developed complications much faster and more severely than those with non-fulminant diabetes.

The difference between fulminant and non-fulminant is the speed and intensity at which the disease develops. Fulminant Type 1 diabetes typically develops suddenly with near total loss of beta cell function. This type of diabetes is confirmed with testing c-peptide levels. Non-fulminant type 1 diabetes has residual c-peptide levels that eventually taper to undetectable. Sometimes this is seen through many years of the Honeymoon Period.

This study may be the antithesis of conventional wisdom for preventing complications. Staking all hopes on blood sugar control is heavily optimistic. Yes controlling blood sugar does lessen the workload for existing beta cells, and thus extends the lifespan of each beta cell. Research suggests that c-peptide offers protection to beta cells, both from apoptosis (cell death) and encourages new cell growth. This new cell growth applies to beta cells and other cells of the body that endure long-term Type 1 diabetes complications.

Diabetics are instructed that maintaining normal blood sugars is the Holy Grail of preventing long-term complications. Yes and no. The truth is controlling your blood sugar will not allow complications of Type 1 diabetes to develop as quickly, presuming you still had some level of beta cell function upon diagnosis (i.e., c-peptide). That doesn't sound like a reward as much as it does a delayed punishment. I'd like c-peptide with my insulin, please. It's off the à la carte menu? That's fine - serve it up! I want to thank Klausen for bringing this study to my attention.

Green Light for DiabeCell Phase 1

Living Cell Technologies has been given the go ahead to conduct clinical trials of its DiabeCell diabetes product in New Zealand.

DiabeCell is a porcine islet cell product for the treatment of insulin- dependent diabetes. The pig cells are injected into the body without any immunosuppressant drugs. The cells produce insulin to help regulate blood glucose levels appropriate to the amount of glucose detected in the blood stream of the diabetic recipient.

The Medical Director of Living Cell Technologies explains that DiabeCell offers considerable advantages over other available treatments in addition to the fact there is no need for immuno-suppressive drugs. Anther problem of islet transplants is the strain on the supply of islets. This is not a problem with the DiabeCell because their supply of cells derive from natural biocertified pig herds, unlike human organ donors.

LCT's application is to conduct the clinical trial of its DiabeCell product on 8 long standing Type 1 diabetics. The clinical trial is expected to be approximately 12 months in duration. This will then be followed by a trial on a larger scale. The trial will be conducted at a New Zealand hospital and involves the simple injection of encapsulated islets into the abdomen of the diabetic patients. It is anticipated that the trial would start by the end of 2007.

Customer for Life - but only what THEY want to Sell

While patrolling the PubMed database this weekend, I came across a very interesting study that investigated the effects of new insulins on insulin and C-peptide antibodies, insulin dose, and diabetic control. Please note - this study was published in 1983. After reading -- I invite EVERYONE to let me know if it is possible to get purified pork insulin and whether or not you have been on it-- and if you have seen a difference in your diabetes control. Please?

24 diabetic patients using bovine (beef) insulin and possessing insulin antibodies underwent a study of the immunological and clinical consequences of changes in both purity and species of their insulin. The new insulin regimes tested were one of three: a) purified bovine insulin, b) highly purified porcine insulin, and c) semisythetic human insulin.

The patients underwent 3 consecutive 4-month periods on each insulin regimen. The average insulin antibody levels changed little on purified bovine (beef) insulin; actually increased on semi-synthetic human insulin but fell substantially on highly purified porcine insulin. Okay - so this means, in lay terms that the patient's insulin antibodies (the stuff killing your islets) remained relatively the same on beef insulin but became categorically HIGH on synthetic human insulin. And most importantly - to me-the highly purified porcine insulin actually DROPPED the insulin antibodies. Of course - it would cost big pharmaceutical companies more to manufacture highly purified porcine insulin.

C-peptide antibodies fell significantly and continuously throughout the study. The slower rate of fall in C-peptide antibody levels is likely to be due to the prolonged half-life of circulating exogenous proinsulin in the presence of insulin antibody. Although insulin dose remained constant the incidence of hypoglycaemic episodes did not increase and glycosylated haemoglobin levels rose significantly when patients were on porcine insulin. The deterioration in diabetic control may have been due to greater temporal mismatch between insulin needs and insulin availability with pork or human insulin than with beef insulins, and to reduced insulin antibody levels.

The use of purer insulins which more closely resemble the human form can cause a significant reduction in levels of insulin and C-peptide antibodies. These changes may not necessarily produce better diabetic control. Recent studies have shown that a depletion of C-peptide in the body results in a greater chance of microvascular complications associated with diabetes.

This study was published around the time when all of the synthetic human insulins were sweeping the Nation. I tried calling my local CVS Pharmacy on Saturday morning to see if I could get some purified porcine insulin. No such luck. Go figure. The big guys were successful at convincing the medical community and patients that no other insulin is better. Correction - no other insulin is cheaper to manufacture and that means it is better for them. And the importance of C-peptide was overlooked entirely - or was it? C-peptide prevents the complications associated with injecting insulin - but that sounds like another marketable drug. After all - synthetic human insulin doesn't have C-peptide. REAL HUMAN INSULIN does (the way it comes out of the beta cells, in natural form, it does)!!! And as long as your body is producing insulin antibodies - you NEED their synthetic insulin (conveniently -- the only kind you can buy). Best business model - customer for life!

Pig Islets 10 Years and Counting

In 1996 a 41 year old male (a type 1 diabetic for 18 years) was injected with biocapsules containing pig islets to regulate his blood sugar level. The transplanted cells helped reduce the patient's insulin requirement by 34% for over a year, which provided better control. By 2005 the patient's glycated hemoglobin levels (HbA1c) remained lower than the pre-transplant levels.

Ten years later, the patent contacted Living Cell Technologies to inform them that he believed the transplanted pig islets were still alive and well. After tests were conducted, it was concluded that the pig cells were (as he reported) still functioning. This proved that the LCT patented technology for xenotransplantation was effective. It allows the islets to survive at least ten years in a micro-capsule coating and continue to release insulin into the patient's bloodstream without immune suppression. After tests we conducted on the type of insulin present in the patients blood - it was with 100% certainty that it was pig and not human insulin.

LCT has significantly advanced the encapsulation process since the 1996 clinical trial and there is an even greater understanding and control over the longevity and robustness of the encapsulation process, as well as the porcine islet cells. LCT will be trialing the DiabeCell pig islet cell transplant in patients in a phase I/IIa clinical trial, expected to begin in Quarter 2, 2007. In addition, LCT is awaiting approval to conduct an additional trial in New Zealand this year with a different treatment protocol. Subsequent trials in the US or Europe are intended following initial results from these studies.

If overseas trials are coming through with flying colors - why aren't we doing this yet? C'mon USA - where's your competitive spirit? All these pigs up in Spring Point might be put to good use, after all. Oink Oink.

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