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

June 19, 2026 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

ASSESSMENT OF THE NATURAL HISTORY AND PROGNOSTIC FACTORS OF THERAPEUTIC RESPONSE IN SUB-PHENOTYPES OF PATIENTS WITH OBESITY: THE BOLOBE STUDY (BOLOgna for OBEsity Follow-up BOLOBE)

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Bologna
      • Bologna, Bologna, Italy, 40138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cardiometabolic events at 5 and 10 years
Time Frame: 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
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of obesity phenotypes and their association with clinical outcomes
Time Frame: 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.
Baseline characteristics and outcomes assessed up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2026

Primary Completion (Estimated)

May 1, 2036

Study Completion (Estimated)

March 1, 2038

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOLOBE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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