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Principal Investigator: Prof. Stefano del Prato


Brief description:

The Metabolism Unit of the Department of Clinical and Experimental Medicine of the University of Pisa has a long standing tradition and a high international reputation in the area of metabolic diseases (188 original articles published in peer reviewed journal the last 10 years). The Unit consists of 3 fully equipped metabolic wards for clinical research and 4 laboratories with 2 PhD, 4 biologist and 4 technicians employed full time, an outpatients clinic and a 10 bed internal medicine ward where 4 full-time MD work. The Metabolism Unit main research areas of expertise are in the field of metabolism and cardiovascular disease, its major lines of research are:

  • Insulin action on peripheral glucose uptake and on liver glucose production
  • Incretins effect on insulin secretion Insulin action on ion homeostasis, vascular tone and on the sympathetic nervous system.
  • Haemodynamic and metabolic consequences of obesity.
  • Heart metabolism,
  • Epidemiology of diabetes and cardiovascular disease
  • Vascular imaging and functions.
  • The Department of Endocrinology and Metabolism has long and successful history of participating in EU-funded projects (EURODIAB IDDM Complications Study, EURODIAB Prospective Complications Study, DE-PLAN Study) and in large international trials (for instance, the IDNT - promoted by the Collaborative Study Group - and the on-going ALTITUDE Study) in the fields of diabetes and its long-term complications. Furthermore, the Department has successful history at both leadership (coordinator) and participant level in large-scale national studies such as GENFIEV (Genetic and Pathophysiology of Type 2 Diabetes Evolution; NCT00879801), MIND-IT (Multifactorial Intervention in Type 2 Diabetes – Italy; NCT01240070) and RIACE (Renal Insufficiency And Cardiovascular Events; NCT00715481) promoted by the Italian Society of Diabetology. Prof. Del Prato and his research coworkers and partners have extensive experience in the recruitment of patients and subjects into research trials. Expertise and partnerships have been developed and established in the field of cellular and molecular biology and genetic analyses.

Two groups of this institution are involved in the ePREDICE project:


The first group, lead by Prof. Andrea Natali

Main tasks attributed:

  • Lead coordinator of WP05 Microvascular endothelial function - Endothelial function.
  • Responsible for organising and managing the data collection of endothelial microvascular dysfunction; specifically:
  • Centre selection (n=10/15) on the bases of local resources.
  • Organization, together with ITAMAR, the producer of EndoPat2000®, of a system (telephone and on site intervention) to provide continuous technical support and assistance to all centres.
  • Preparation of the operations manual and organization of courses for personnel training and standardization of the procedure.
  • Organization of a web based system for data transfer and set up of the central data-management office for storage, continuous quality control and analysis.


The second group, lead by Prof. Stefano Del Prato

Main tasks attributed:

This group will be responsible for:

1. Recruiting, sampling, and monitoring at least one hundred non-diabetic people with hyperglycaemia currently under lifestyle intervention.

2. As a non-core pilot study, our specific aim will be to explore in these subjects the so called “vascular or endothelial competence” that might be the results of the balance between sustained vascular damage and repair capacity. These two opposite phenomena can be tracked down and followed-up by assessment of cellular markers namely, endothelial derived microparticles (EdMP), expression of disrupted endothelial integrity, and endothelial progenitor cells (EPC), marker of endogenous capacity for repair. These cellular markers of endothelial competence will be evaluated along the 36 months of treatment and clinical follow-up together with secondary endpoints such as flow-mediated dilation, pulse wave velocity, intima-media thickness, biomarkers of inflammation as well novel biomarkers of subclinical atherosclerosis as described in the e-PREDICE Project. Possibly, in vivo studies will be joined by in vitro studies on isolated, cultured and ex-vivo enriched EPCs to assess changes in several functional properties in subjects with pre-diabetes.


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