Metabolic syndrome in people treated with antipsychotics: a multimethod investigation of genetic, behavioural and environmental risk factors (RISKMet)

Many people suffering from mental disorders in both childhood and adulthood are treated with AntiPsychotics (APs) and are at significant risk for concomitant physical illness, including Metabolic Syndrome (MetS). Pathogenetic and biological mechanisms, unhealthy lifestyle habits, underutilization of health care services, adverse effects of common drug treatments, and substance use contribute to the increasing rate of medical conditions in these patients. However, few is known about behavioural, psychological and clinical predictors and consequences of MetS in APs consumers. In order to overcome existing limitations, RISKMet will address 3 main objectives:

• To identify risk factors for MetS using a case-control design. We will recruit (among both adult and paediatric population) two groups of subjects: "Cases" (MetS+) and sex- and age-matched "Controls" (MetS-). This aim will include an assessment of familiarity for MetS and both psychological and functional risk factors (e.g. disability, quality of life, functioning levels, quality of sleep)
• To perform an indepth clinical and biological characterization of patients with (MetS+) and without (MetS-) MetS. This aim will study body parameters and their influencing factors at the whole organism level. At two time points (TO and after 3 months, T3), participants will undergo a structured physical examination and blood sampling (e.g. body weight, height, waist and hip circumferences, heart rate, systolic and diastolic blood pressure, fasting blood glucose, C-peptide, HbA1c, triglycerides, HDL cholesterol, LDL cholesterol and total cholesterol, oxidized LDL and high-sensitivity C-reactive protein, AST, ALT, gammaGT, and zonulin concentration). Moreover, we will deeply assess pharmacological treatments and will examine genetic variability associated with predisposition to sensitivity or resistance to MetS symptoms.
• To identify behavioural patterns of both patients and healthy individuals using a prospective cohort design. Behavioural markers will be assessed twice: at TO and at 3-month FU (T3) in both MetS+ and MetS- and in healthy control sample. Both at TO and T3, for seven days, PA will be monitored with a wrist-worn accelerometer that will be wear for a 24-hour period, while eating behaviour (daily caloric intake, binge eating episodes, night-time eating, cravings, fast food consumption, and satiety) will be monitored using a mobile-based Experience Sampling Method (ESM). Participants (or caregivers) will provide information about their mood, stressors, eating behaviours, dietary restraint, and various other assessments of the psychosocial environment.

RISKMet - with a combination of different study designs, methodologies and assessment variables - will identify potential risk and protective factors associated with the development of MetS in clinical populations and will provide guidance to health workers as how to improve the management of patients treated with APs. By expanding current knowledge for people treated with APs, the project will introduce evidence-based strategies for the management of comorbidities associated with the treatment of AP and improve early diagnosis by identifying specific risk factors and pathways.