Natural history and prognostic factors of therapeutic response in sub-phenotypes of obesity
Official title: 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)
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07666425 · Data updated 2026-11-12
This study follows adults with obesity or overweight to see how different subtypes respond to obesity therapies using data and machine learning.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Status | Recruiting |
| Started | May 30, 2026 |
| Main results expected | May 2036 |
| Study ends | March 2038 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT07666425 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with BMI ≥ 30 kg/m² (or BMI ≥ 25 with at least one cardiometabolic comorbidity) who can provide informed consent.
✕Probably not a fit
Patients whose obesity is due to hypothalamic-pituitary or adrenal disorders or syndromic obesity may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center observational study that will collect retrospective and prospective data on patients diagnosed with obesity or overweight. The goal is to build prognostic and predictive models of how patients respond to obesity therapies, using statistical methods and machine learning for research purposes. Interim analysis will focus on the retrospective cohort with at least five years of follow-up from the start of data collection. Data will include laboratory results, treatments, and outcomes over time to identify factors associated with response. The study requires informed consent and excludes obesity caused by certain endocrine or syndromic conditions.
Why it matters
Potential benefit: If successful, the models could help predict which patients are more likely to respond to specific obesity therapies.
How similar studies have gone: Previous research in obesity has used observational data to develop predictive models, but this study applies machine learning to sub-phenotypes for prognosis and therapy response within a single center.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, Italy Recruiting
Study contacts
- Study coordinator: Maria Letizia Petroni, MD
- Email: marialetizia.petroni@unibo.it
- Phone: 0512143281
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.