BVAS - Molecular Interplay between atherosclerotic plaque and bone metabolism in diabetic patients with arterial disease

Project objectives

Observational study of male or female (post menopausal) patients over the age of 50, affected by vascular disease and/or diabetes and scheduled for major/minor amputation surgery of the foot or leg or carotid endarterectomy.

The study's general objective is to evaluate the involvement of processes that regulate bone formation in vascular calcifications and their association with plaque severity and skeletal fragility. Finally, only for patients suffering from diabetic vascular disease, glycemic fluctuations will be evaluated before and after the intervention through the use of a medical device which allows continuous monitoring of glycemia.

The study will last 36 months and a total of at least 80 patients will participate in this research, all recruited at the Campus Bio-Medico University Hospital Foundation.

For enrolled patients, a first visit will be performed to evaluate the general clinical history, the presence of comorbidities and pharmacotherapy; general objective examination and anthropometric parameters (weight, height, BMI, waist, abdomen and hip circumferences); Following a positive finding in the evaluation of the eligibility criteria for the study, the following examinations, tests and procedures will be carried out:

> Routine venous blood sampling to evaluate serum levels of inflammation indices (ESR, CRP), lipid and glycemic profile (total cholesterol, HDL, triglycerides, LDL, blood glucose, HbA1c), electrolytes (calcium, phosphorus, magnesium), renal function (creatinine, eGFR), others (GOT, GPT, gGT, Hb, uric acid).

> Administration of a validated questionnaire for the evaluation of non-vertebral fractures.

> Double-projection chest X-ray taken during hospitalization to identify any vertebral fractures.

> Eco-color-Doppler of the supra-aortic trunks or of the venous circulation of the lower limbs based on the type of intervention that will be performed.

> Application of the medical device for continuous blood glucose monitoring (Freestyle libre – Flash Glucose Monitoring) only for patients suffering from diabetic vascular disease.

> Acquisition of biopsies:

• Bone, endothelial, and nerve (sciatic and sural nerve) tissue biopsies for patients scheduled for minor amputation surgery (first metatarsal ray) and/or major amputation of the foot/leg.
• Endothelial tissue biopsy for patients scheduled for carotid endarterectomy surgery.

Bone, endothelial and nerve tissue biopsies will be obtained directly during surgery and therefore are not to be considered additional procedures.

During the course of the study, the investigators will record in an electronic Data Collection Form, specially developed for the study, specific information concerning data already contained in the medical record/health documentation (e.g. medical history), both those that will be recorded in the medical record during the observation period of the study, including any reports of specialist visits performed.

Participation in the clinical study does not involve any additional costs for you.

The study foresees the carrying out of the usual check-ups which include a physical examination, check of drug therapies, blood samples and eco-color Doppler.

Start and end date

June 2022 - December 2024

Project Manager

Prof. Francesco Stilo, Head of Research Unit and Prof. Francesco Spinelli, UOC Director

Coordinating institution of the project

University Polyclinic Foundation Campus Bio-Medico

Project funding source