Clinical trial

ASSESSMENT OF THE NATURAL HISTORY AND PROGNOSTIC FACTORS OF THERAPEUTIC RESPONSE IN SUB-PHENOTYPES OF PATIENTS WITH OBESITY: THE BOLOBE STUDY

Recruiting now · Not applicable · 1 countries · Registry ID NCT07666425

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObese Adults, Overweight , Obesity

Full registry criteria

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

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Incidence of cardiometabolic events at 5 and 10 yearsUp 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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

IRCCS Azienda Ospedaliero - Universitaria di Bologna🇮🇹 Bologna, Bologna, Italy

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Maria Letizia Petroni, MDContact