Obese Adults, Overweight , Obesity
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Obesity secondary to hypothalamic-pituitary disorders * Obesity secondary to adrenal disorders * Syndromic obesity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cardiometabolic events at 5 and 10 years | Up to 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
| Measure | Time frame | Description |
|---|---|---|
| Identification of obesity phenotypes and their association with clinical outcomes | Baseline characteristics and outcomes assessed up to 10 years | Identification of homogeneous patient subgroups based on clinical, metabolic, and demographic characteristics, and evaluation of their association with cardiometabolic outcomes. |
Countries
Italy
Contacts
CONTACTMaria Letizia Petroni, MD
Outcome results
None listed