Nicola Scopinaro, MD

CONTACT

Lead Sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Collaborators

Age

35 - 70 years

Sex

ALL

Healthy Volunteers

No

•age: 35-70 years
•diabetes duration: \>5 years
•documented poor glycemic control (HbA1c =\>8% despite medical treatment according to GCP)
•presence of comorbidities or complications (e.g. dyslipidemia, arterial hypertension, neuropathy, retinopathy, CVD, previous stroke or TIA, lower limb amputation)
•availability to comply with the entire follow-up

•general contraindications to BPD (applies also to medical controls)
•presence of anti-islet or anti-GAD antibodies or plasma C-peptide concentration \<0.5 mcg/L
•blindness
•severe concomitant medical conditions (e.g. liver cirrhosis, renal failure, collagen diseases, severe endocrinopathies)
•heart failure
•recent history (less than 12 months) of myocardial infarction, stroke or TIA
•unstable angina
•pregnancy
•previous or concomitant malignancy
•severe active inflammatory, neurologic, or cardiovascular conditions
•geographic inaccessibility
•any condition which, in the opinion of the Principal Investigator, may make risky the participation in the study or bias the results