THE PROJECT


  

Background:

The “Early Prevention of Diabetes Complications in People with Hyperglycaemia in Europe” project (ePREDICE) was born as a response to a call of a specific health topic of the Program of Cooperation 2011 FP7, specifically sought for Investigator-driven clinical trials to reduce diabetes complications (HEALTH 2011.2.4.3-1).

Europe, as the majority of the regions of the world, is suffering of an increase in the incidence and prevalence of type 2 Diabetes (T2D). According to the recently published IDF-Atlas of Diabetes, in 2011 the prevalence of Diabetes in the European region was 8.1% (52 million) among adult people 20-79 years. The estimated figure for 2030 is 9.1% (64.2 million). Impaired Glucose Tolerance (IGT), also known as pre-diabetes state, affects another 8.6 % (or 63 million) and although the estimate of the prevalence seems to stabilize in 8.5% by 2030, the absolute number will increase to 71.5 millions. Currently (2011) it is estimated that in the European region ~30% of the Global Health Expenditures are due to diabetes care with majority associated to chronic complications care.

Quality of life is dramatically reduced in individuals with diabetes due to chronic treatment and steadily arising disease complications, especially of microvascular origin; i.e. retinal, renal, and peripheral neural complications. The goal of the ePREDICE project is the prevention of the development of diabetes major microvascular complications.

A significant proportion of pre-diabetics, show macro and micro vascular complications associated with hyperglycaemia. Although many trials have demonstrated the efficacy of lifestyle and pharmaceutical interventions in diabetes prevention, no trial has evaluated the extent to which mid- and long-term complications can be prevented by early interventions on hyperglycaemia. Including people, who have a significantly increased diabetes risk, would be a more effective and more rationale target for intervention in order to reduce the incidence of diabetes complications.

 

Objectives:

The general objective of the ePREDICE project is to assess the mid and long-term effects on multiple complications of early intensive management of hyperglycaemia with linagliptin, metformin or their combination added to lifestyle intervention (LSI) (diet and physical activity), compared with LSI alone in adults with non-diabetic intermediate hyperglycaemia (IFG, IGT or both).

The target population corresponds to males and females with pre-diabetes (IFG, IGT or both) aged 45 to 74 years selected from primary care screening programs in 15 clinical centres from 12 countries: Australia, Austria, Bulgaria, Germany, Greece, Italy, Lithuania, Poland, Serbia, Spain, Switzerland and Turkey. (N=3000).

The primary endpoint is a combined continuous variable: “the microvascular complication índex" (MCI) composed by a linear combination of the Early Treatment Diabetic Retinopathy Study Scale score (based on retinograms), the level of urinary albumin to creatinine ratio, and a measure of distal small fibre neuropathy (sudomotor test by SUDOSCAN), measured during baseline visit and at 36th and 60th month visits after randomisation.

In addition, this project will include the evaluation of early novel serological biomarkers of systemic inflammation, early micro-vascular damage, NAFLD, insulin sensitivity and insulin secretion, and measures of quality of life, sleep quality (somnograms) and neuropsychological evaluation. Vascular function and structure will be evaluated in a subset of participants (n=1000), including cIMT and microvascular endothelial function measured by EndoPAT.

 

Expected results:

By evaluating the effect of aggressive treatments in pre-diabetes for the early prevention of diabetes complications, this project has the potential of changing the current paradigm of early management of hyperglycaemia, and will enable to:

  • Show whether early intensive combined lifestyle and pharmacotherapy targeting to correct hyperglycaemia early can help in reaching the key indicators of good diabetes care and avoidance of diabetes complications.
  • Characterize for the first time those individuals who will develop early complications.
  • Identify which complication appear in the first place and the cumulative frequency of various complications.
  • Provide data on cost-effectiveness to guide clinical decisions of treatment.
  • Guide the primary care which intervention are the most effective for preventing diabetes complications.
  • Explore new screening and diagnostic technologies to be included in usual clinical practice.
  • Simplify the clinical management of hyperglycaemia, avoiding the necessity of frequent blood glucose monitoring.

The ultimate goal of this project is the development of a standardized core protocol for the prevention of microvascular complications, the leading cause of blindness, renal end-stage disease and non-traumatic lower limb amputations in Europe, impacting social cost as a result not only in health care, but also in disabilities at work. The resulting best protocol can be implemented into the European national health care systems under practical and socio-economic conditions. Thus, exactly fitting into the above-mentioned European Policy, the project will bundle multidisciplinary international, national and regional expertise to reduce the human and financial burden of the disease and to increase the quality of life for people.

 

Project structure:

The project is divided into 10 Work Packages (WP), each of which focuses on a specific area of responsibility and expertise. Though individual functions are coordinated by particular Work Package Leaders, close cooperation between all WPs is vital to the success of the project.

 

 

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