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Methods

METHODS USED IN THE ACTION LADA STUDY

The Action LADA study will cover three aspects of the disease.

I. Firstly it will establish how prevalent – or common – the disease actually is and obtain some clinical information about who is likely to have it.

II. Secondly it will analyse the genetic and metabolic characteristics of those screened who actually have LADA, approximately 10% of the people sampled.

III. Thirdly Action LADA will recruit a small number of people who have participated in the first two parts of the study, and, who are willing to take part in a trial of a new therapy. This therapy is aimed at preventing LADA progressing to the insulin dependent form of the disease.

Image map of Europe showing location of centres Israel Denmark Austria Italy Spain UK Finland Germany France
Select a country from the above map to see details of a European Centre (full text list)

I. Epidemiology of LADA – how common is it and who has it?

Aims - The Action LADA study aims to define the prevalence of LADA in Europe. This estimate of how common LADA is will be based on a sample of patients with diabetes asked to participate at each of the 9 clinical centres involved in the study. These centres are based in counties the length and breadth of Europe from Finland in the north to Italy in the south, and Austria in the east to Northern Ireland in the west.

People who have been diagnosed with diabetes for less than 5 years and are between the ages of 30 and 69 years of age will be asked if they wish to be involved in the study. They can be on any form of diabetes treatment either diet, oral hypoglycaemic therapy or insulin, although they should not have been started on insulin immediately at diagnosis of diabetes. They should also not be pregnant or have diabetes due to secondary causes. It is hoped that 1000 such patients will be screened at each of the 9 clinical centres.

Patients who fulfil these criteria and who are willing to become part of the study, following detailed explanation from their clinician, will be enrolled and asked for a brief family history of diabetes and other related auto-immune disease. A number of physical measurements will be taken, height, weight and waist circumference, for example. They will also be asked to give a small blood sample (5ml) which will be analysed for the presence of GAD antibodies, the marker of auto-immune diabetes used to define LADA in this study.


II. What are the other immunological markers and genetic and metabolic characteristics of LADA?

Aims - The Action LADA study aims to characterise the disease process in GAD positive patients, that is to say those defined as having LADA. A selected subset of non-LADA patients will also be asked if they would like to participate in this phase of the study for comparison. Again, after full explanation of the purposes of the study by their clinician and with their consent, a small blood sample (approximately 40ml) will be taken for a number of further immunological and metabolic parameters as well as DNA genotyping for major susceptibility genes to type 1 diabetes.

It is hoped that results from these tests will, in the future, enable people presenting with this type of diabetes to be to be rapidly classified for appropriate interventions at an early stage in the disease process. The early diagnosis of LADA can enhance treatment and slow down the destruction of insulin producing pancreatic beta cells and possibly prevent the dependency on insulin.

III. Prevention trial with DiaPep277™

Aims - Following the completion of the first two phases of the study, Action LADA aims to test the effectiveness of a novel therapy in delaying/preventing progression to insulin dependency in LADA patients.

This will be achieved by running a double-blind placebo-controlled trial with the therapeutic agent DiaPep277™. For the prevention trial, we aim to offer the opportunity to approximately 350 LADA patients Europe-wide with defined positivity for auto-antibodies to glutamic acid decarboxylase (GAD) and islet cell antibodies (ICA) but who were initially non-insulin requiring at diagnosis of diabetes.

Further details of this phase of Action LADA will be posted on this web site in the near future.



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