About this trial
The study is observational and single-center and involves (i) the establishment of a retrospective and prospective data collection, and (ii) the development of prognostic and predictive models of response to obesity therapies using statistical modeling and machine learning techniques, exclusively for research purposes.
Data collection will be carried out for each patient diagnosed with obesity or overweight whose first visit to the center occurred from January 1, 2000 up to the start of the study, as well as for patients accessing the center during the subsequent 5 years, including patients who died or were lost to follow-up.
With respect to the primary objective, an interim analysis is planned on the retrospective cohort only, once the collection of data already available at study start has been completed for patients with at least 5 years of follow-up.
Data related to instrumental and laboratory examinations and therapeutic interventions, including pharmacological treatments and group-based educational and behavioral therapies, conducted in accordance with routine clinical practice and the most recent relevant national and international guidelines, will be extracted from the electronic health records routinely used at the study center.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Body mass index (BMI) ≥ 30 kg/m², or BMI ≥ 25 kg/m² with at least one cardiometabolic comorbidity
Provision of written informed consent
Disqualifiers
Obesity secondary to hypothalamic-pituitary disorders
Obesity secondary to adrenal disorders
Syndromic obesity
Trial population
The study population will consist of adult patients meeting the study inclusion and exclusion criteria, with a current or past diagnosis of overweight or obesity defined in accordance with the most recent Italian clinical guidelines and the European framework promoted by the European Association for the Study of Obesity (EASO). Eligible patients will include individuals whose first access to the study site occurred on or after January 1, 2000.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incidence of cardiometabolic events at 5 and 10 years
Occurrence of cardiometabolic events over 5- and 10-year follow-up, including: * Type 2 diabetes mellitus * Atrial fibrillation * Ischemic heart disease * Ischemic stroke * Peripheral arterial disease * Metabolic dysfunction-associated steatohepatitis (MASH) * Obesity-associated nephropathy
Secondary outcomes
Identification of obesity phenotypes and their association with clinical outcomes
Identification of homogeneous patient subgroups based on clinical, metabolic, and demographic characteristics, and evaluation of their association with cardiometabolic outcomes.
Sponsors and contacts
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