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

NCT07666425 | Recruiting

• 1 other identifier: BOLOBE
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese Adults; Overweight , Obesity

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 10 years

Secondary Outcomes (1)

• Identification of obesity phenotypes and their association with clinical outcomes

  Baseline characteristics and outcomes assessed up to 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Obesity secondary to hypothalamic-pituitary disorders
• Obesity secondary to adrenal disorders
• Syndromic obesity

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maria Letizia Petroni, MD

CONTACT

0512143281; marialetizia.petroni@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 24, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): May 1, 2036
• Study Completion (Estimated): March 1, 2038
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

IT (1)