Bariatric Surgery CandidateBAROBS2NCT05743166
Bariatric Surgery Observation Study Part 2
An observational study of Bariatric Surgery Candidate, run by St. Olavs Hospital at 3 sites in Norway.
Trial summary
The goal of this observational study is to explore the longterm effects of two bariatric surgical procedures by inviting patients from three public hospitals who had Roux-en-Y gastric bypass or Sleeve gastrectomy to a follow-up after10-15 years The main question[s] it aims to answer are: The duration of the surgical… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 687 participants
- Where
- 3 sitesNorway
- Study dates
- 28 Mar 2023to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1400 patients who had baratric surgery at three public hospitals in Central Norway from 2010 to 2015 are invited to a follow up in 2023-2025
Who may be able to join
- Bariatric surgery at Namsos Hospital, St. Olavs hospital or Ålesund Hospital from 01.01.2010 to 31.12.2015
Who cannot join
- Not able to consent for participation
- Includable participants not longer living in Norway
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Helse Møre og Romsdal
Ålesund, 6017
Helse Nord-Trondelag
Namsos, 7800
St. Olavs Univeristy Hospital
Trondheim, 7030
About this study
Official title: Bariatric Surgery Observation Study Part 2 An Observational Study of Patients Who Underwent Bartiatric Surgery in Public Hospitals in Central Norway 2010-2015.
The goal of this observational study is to explore the longterm effects of two bariatric surgical procedures by inviting patients from three public hospitals who had Roux-en-Y gastric bypass or Sleeve gastrectomy to a follow-up after10-15 years
The main question[s] it aims to answer are:
- The duration of the surgical method on weight reduction and remission of comorbidities
- Theprevalence of complications and new morbidities after the surgical procedures Participants will be asked be asked to
- fill inn questionnaires,
- have a clinical examinition
- have an interview with nurse and doctor
- have blood samples taken
- undergo other investigations
Read the detailed description
The BAROBS project is a collaberation between three public hospitals in Norway exploring the concequeces ten years or more after undergoing gastric bypass or sleeve gastrectomy for severe obesity.
1400 patients who underwent bariatric surgery at the three hospitals will be invited to a follow up including antrophometric, meassurment of bodily composition by bioimpedance and DXA, blood samples, questionnaires on sosioeconomic topics, symptoms and quality of life, continous glucose monitoring, dental examination, and other clinical evaluation.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Bariatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Also called Roux-en-Y gastsric bypass, Sleeve gastrectomy
JDF11 JDF41 JDF97
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term weight loss
Total weight loss after bariatric surgery
Measured: 10-15 years after surgery
Secondary outcomes (2)
Remission of comorbidities after bariatric surgery
Remission of Type 2 Diabetes Mellitus, Hypertension and Sleep Apnoe
Measured: 10-15 years after surgery
Quality of life after bariatric surgery
Health related quality of life, SF -36
Measured: 10-15 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start28 Mar 2023
- Primary completion31 Dec 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Retrospective
- Enrolment
- 687 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF, Helse Møre og Romsdal HF
- Responsible party
- Sponsor
- Investigators
- Jorunn Sandvik, PhD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743166
- Sponsor's protocol ID
- 535140
- Acronym
- BAROBS2
- Status last verified
- May 2026
- First submitted
- 14 Feb 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Surgery Observation Study Part 2 An Observational Study of Patients Who Underwent Bartiatric Surgery in Public Hospitals in Central Norway 2010-2015.
- ClinicalTrials.gov ID
- NCT05743166
- Acronym / sponsor ID
- BAROBS2 / 535140
- Conditions
- Bariatric Surgery Candidate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 687 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF, Helse Møre og Romsdal HF
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 24 Feb 2023 (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 goal of this observational study is to explore the longterm effects of two bariatric surgical procedures by inviting patients from three public hospitals who had Roux-en-Y gastric bypass or Sleeve gastrectomy to a follow-up after10-15 years
The main question[s] it aims to answer are:
- The duration of the surgical method on weight reduction and remission of comorbidities
- Theprevalence of complications and new morbidities after the surgical procedures Participants will be asked be asked to
- fill inn questionnaires,
- have a clinical examinition
- have an interview with nurse and doctor
- have blood samples taken
- undergo other investigations
Detailed description
The BAROBS project is a collaberation between three public hospitals in Norway exploring the concequeces ten years or more after undergoing gastric bypass or sleeve gastrectomy for severe obesity.
1400 patients who underwent bariatric surgery at the three hospitals will be invited to a follow up including antrophometric, meassurment of bodily composition by bioimpedance and DXA, blood samples, questionnaires on sosioeconomic topics, symptoms and quality of life, continous glucose monitoring, dental examination, and other clinical evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1400 patients who had baratric surgery at three public hospitals in Central Norway from 2010 to 2015 are invited to a follow up in 2023-2025
Key inclusion criteria (1 listed)
- Bariatric surgery at Namsos Hospital, St. Olavs hospital or Ålesund Hospital from 01.01.2010 to 31.12.2015
Key exclusion criteria (2 listed)
- Not able to consent for participation
- Includable participants not longer living in Norway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryAlso: Roux-en-Y gastsric bypass, Sleeve gastrectomyJDF11 JDF41 JDF97 | Procedure or surgery | – |
Primary outcome
Long-term weight loss
Time frame: 10-15 years after surgery
Total weight loss after bariatric surgery
2 secondary outcomes
Remission of comorbidities after bariatric surgery
Time frame: 10-15 years after surgery
Quality of life after bariatric surgery
Time frame: 10-15 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jorunn Sandvik, PhD principal investigator
St. Olavs Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate, run by St. Olavs Hospital at 3 sites in Norway.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term weight loss (time frame: 10-15 years after surgery). 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 29 May 2026.