Obese AdultsBOLOBENCT07666425
ASSESSMENT OF THE NATURAL HISTORY AND PROGNOSTIC FACTORS OF THERAPEUTIC RESPONSE IN SUB-PHENOTYPES OF PATIENTS WITH OBESITY: THE BOLOBE STUDY
An observational study of Obese Adults and Overweight , Obesity, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obese Adults, Overweight , Obesity
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2026to Mar 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Obesity secondary to hypothalamic-pituitary disorders
- Obesity secondary to adrenal disorders
- Syndromic obesity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, 40138
Maria Letizia Petroni, MD, marialetizia.petroni@unibo.it
About this study
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)
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.
Read more
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
- Medical subject headings
- Overweight, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 10 years
Secondary outcomes (1)
Identification of obesity phenotypes and their association with clinical outcomes
Identification of homogeneous patient subgroups based on clinical, metabolic, and demographic characteristics, and evaluation of their association with cardiometabolic outcomes.
Measured: Baseline characteristics and outcomes assessed up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start30 May 2026
- Primary completionMay 2036 (estimated)
- Study completionMar 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese AdultsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666425
- Sponsor's protocol ID
- BOLOBE
- Acronym
- BOLOBE
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07666425
- Acronym / sponsor ID
- BOLOBE / BOLOBE
- Conditions
- Obese Adults, Overweight , Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 30 May 2026 (actual)
- Primary completion
- May 2036 (estimated)
- Study completion
- Mar 2038 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Obesity secondary to hypothalamic-pituitary disorders
- Obesity secondary to adrenal disorders
- Syndromic obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Identification of obesity phenotypes and their association with clinical outcomes
Time frame: Baseline characteristics and outcomes assessed up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obese Adults and Overweight , Obesity, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Letizia Petroni, MD (0512143281, marialetizia.petroni@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiometabolic events at 5 and 10 years (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.