Bariatric Surgery Observation Study Part 2 (BAROBS2)

May 27, 2026 updated by: St. Olavs Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

687

Contacts and Locations

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

Study Locations

  • Norway
      • Namsos, Norway, 7800
        • Helse Nord-Trondelag
      • Trondheim, Norway, 7030
        • St. Olavs Univeristy Hospital
      • Ålesund, Norway, 6017
        • Helse Møre og Romsdal

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • Bariatric surgery at Namsos Hospital, St. Olavs hospital or Ålesund Hospital from 01.01.2010 to 31.12.2015

Exclusion Criteria:

  • Not able to consent for participation
  • Includable participants not longer living in Norway

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
Long-term weight loss
Time Frame: 10-15 years after surgery
Total weight loss after bariatric surgery
10-15 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission of comorbidities after bariatric surgery
Time Frame: 10-15 years after surgery
Remission of Type 2 Diabetes Mellitus, Hypertension and Sleep Apnoe
10-15 years after surgery
Quality of life after bariatric surgery
Time Frame: 10-15 years after surgery
Health related quality of life, SF -36
10-15 years after surgery

Collaborators and Investigators

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

Sponsor

St. Olavs Hospital

Collaborators

Helse Nord-Trøndelag HF
Helse Møre og Romsdal HF

Investigators

  • Principal Investigator: Jorunn Sandvik, PhD, St. Olavs Hospital

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)

March 28, 2023

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 535140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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