Weight LossFatWestNCT01533142
Bariatric Surgery on the West Coast of Norway (Vestlandet)
An observational study of Weight Loss and Diabetes Mellitus, run by Helse Fonna at 1 site in Norway.
Trial summary
Bariatric surgery of morbid obesity was first located at Førde Central Hospital, but it is now an established treatment at several other hospitals in the health region (Voss Hospital (Helse Bergen), Haugesund Hospital (Helse Fonna) Stavanger University Hospital ((SUS) Helse Stavanger). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Weight Loss, Diabetes Mellitus, Urinary Incontinence
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 543 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2012to Feb 2020
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Both sexes 18-60 years old Patients with morbid obesity that is applied to the bariatric surgery. Signed informed consent
Who may be able to join
- Both sexes 18-60 years old
- Patients with morbid obesity that is applied to the bariatric surgery.
- Signed informed consent
Who cannot join
- Patients who become pregnant in the follow-up period will not continue in the study but the data will be treated as lost too follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bariatric Surgery on the West Coast of Norway (Vestlandet): Prospective Study of Overweight People Undergoing Bariatric Surgery
Bariatric surgery of morbid obesity was first located at Førde Central Hospital, but it is now an established treatment at several other hospitals in the health region (Voss Hospital (Helse Bergen), Haugesund Hospital (Helse Fonna) Stavanger University Hospital ((SUS) Helse Stavanger). Surgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund: gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion with duodenal switch (BPD / DS) and sleeve gastrectomy . The investigators have then in Helse-Vest a unique opportunity to examine the various clinical and metabolic effects from different surgical methods.
This project is part of the regional strategic research initiative in the Helse Vest
Read the detailed description
Primary endpoints for the study are weight loss and self-reported quality of life (QoL) evaluated by Short Form (SF)-36 and Impact of Weight Wed Quality of Life-Lite (IWQOL-Lite)) Our hypothesis is that patients operated with RYGBP (Roux A-Y Gastric Bypass) and BPD / DS (biliopancreatic diversion with duodenal switch) have the same weight and same QoL after 5 years of follow-up as patients treated with gastric sleeve (laparoscopic gastric sleeve (LSG)) We will also compare the groups with respect to a number of secondary endpoints
400 patients (approximately 100 patients / institution) will be included in the main study. Some of the programs that run on secondary endpoints will be conducted separately under study at each hospital. These studies will be reported in separate articles.
- Conditions
- Weight Loss, Diabetes Mellitus, Urinary Incontinence
- Being tested
- Bariatric surgery
- Keywords
- lipids
- Medical subject headings
- Weight Loss, Diabetes Mellitus, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Patients will be treated with one of two bariatric procedure::
sleeve gastrectomy or gastric bypass
Bariatric surgeryProcedure or surgery
Surgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund: gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion with duodenal switch (BPD / DS) and sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| surgical methods | Different methods are used among hospitals in Helse-Vest, and this allows us to compare different clinical and biological effects following bariatric surgery different methods) among a homogeneous population in the western part of Norway (Vestlandet Receives: Procedure: Bariatric surgery | |
| Morbid obesity | Not described Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: From 1 year and up to 5 years
Secondary outcomes (1)
remission of diabetes mellitus type 2
Measured: from 1 year up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Fonna
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Forde, Helse-Bergen HF
- Responsible party
- Principal investigator, Bjørn Gunnar Nedrebø, MD, PhD, Helse Fonna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533142
- Sponsor's protocol ID
- 2010/3287
- Acronym
- FatWest
- Status last verified
- May 2026
- First submitted
- 9 Feb 2012
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grymyr LMD, Nadirpour S, Gerdts E, Nedrebo BG, Matre K, Cramariuc D. Long-Term Trajectories of Left Heart Geometry, Mechanics, and Oxygen Demand After Bariatric Surgery. Circ Heart Fail. 2025 May;18(5):e012367. doi: 10.1161/CIRCHEARTFAILURE.124.012367. Epub 2025 Apr 7.
PubMed 40190274Grymyr LMD, Mellgren G, McCann A, Gerdts E, Meyer K, Nadirpour S, Ferno J, Nedrebo BG, Cramariuc D. Preoperative risk factors associated with left ventricular dysfunction after bariatric surgery. Sci Rep. 2024 Jan 25;14(1):2173. doi: 10.1038/s41598-024-52623-1.
PubMed 38273044Grymyr LMD, Nadirpour S, Gerdts E, Nedrebo BG, Hjertaas JJ, Matre K, Cramariuc D. One-year impact of bariatric surgery on left ventricular mechanics: results from the prospective FatWest study. Eur Heart J Open. 2021 Aug 20;1(2):oeab024. doi: 10.1093/ehjopen/oeab024. eCollection 2021 Sep.
PubMed 35919265Grymyr LMD, Nadirpour S, Gerdts E, Nedrebo BG, Hjertaas JJ, Matre K, Cramariuc D. Left ventricular myocardial oxygen demand and subclinical dysfunction in patients with severe obesity referred for bariatric surgery. Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):666-674. doi: 10.1016/j.numecd.2020.10.009. Epub 2020 Oct 17.
PubMed 33257189
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Surgery on the West Coast of Norway (Vestlandet): Prospective Study of Overweight People Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01533142
- Acronym / sponsor ID
- FatWest / 2010/3287
- Conditions
- Weight Loss, Diabetes Mellitus, Urinary Incontinence
- Keywords
- lipids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Helse FonnaUniversity, hospital or other
- Collaborators
- Helse Forde, Helse-Bergen HF
- Study start
- Feb 2012
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 15 Feb 2012 (estimated)
- 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.
Bariatric surgery of morbid obesity was first located at Førde Central Hospital, but it is now an established treatment at several other hospitals in the health region (Voss Hospital (Helse Bergen), Haugesund Hospital (Helse Fonna) Stavanger University Hospital ((SUS) Helse Stavanger). Surgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund: gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion with duodenal switch (BPD / DS) and sleeve gastrectomy . The investigators have then in Helse-Vest a unique opportunity to examine the various clinical and metabolic effects from different surgical methods.
This project is part of the regional strategic research initiative in the Helse Vest
Detailed description
Primary endpoints for the study are weight loss and self-reported quality of life (QoL) evaluated by Short Form (SF)-36 and Impact of Weight Wed Quality of Life-Lite (IWQOL-Lite)) Our hypothesis is that patients operated with RYGBP (Roux A-Y Gastric Bypass) and BPD / DS (biliopancreatic diversion with duodenal switch) have the same weight and same QoL after 5 years of follow-up as patients treated with gastric sleeve (laparoscopic gastric sleeve (LSG)) We will also compare the groups with respect to a number of secondary endpoints
400 patients (approximately 100 patients / institution) will be included in the main study. Some of the programs that run on secondary endpoints will be conducted separately under study at each hospital. These studies will be reported in separate articles.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical methods | – | Procedure: Bariatric surgeryDifferent methods are used among hospitals in Helse-Vest, and this allows us to compare different clinical and biological effects following bariatric surgery different methods) among a homogeneous population in the western part of Norway (Vestlandet |
| Morbid obesity | – | Procedure: Bariatric surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Both sexes 18-60 years old Patients with morbid obesity that is applied to the bariatric surgery. Signed informed consent
Key inclusion criteria (3 listed)
- Both sexes 18-60 years old
- Patients with morbid obesity that is applied to the bariatric surgery.
- Signed informed consent
Key exclusion criteria (1 listed)
- Patients who become pregnant in the follow-up period will not continue in the study but the data will be treated as lost too follow up.
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 surgeryPatients will be treated with one of two bariatric procedure:: sleeve gastrectomy or gastric bypass | Procedure or surgery | Morbid obesity, surgical methods |
| Bariatric surgerySurgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund: gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion with duodenal switch (BPD / DS) and sleeve gastrectomy | Procedure or surgery | Morbid obesity, surgical methods |
Primary outcome
weight loss
Time frame: From 1 year and up to 5 years
1 secondary outcome
remission of diabetes mellitus type 2
Time frame: from 1 year up to 5 years
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 2 Jun 2026.
- Derived from this study: PubMed 40190274Grymyr LMD, Nadirpour S, Gerdts E, Nedrebo BG, Matre K, Cramariuc D. Long-Term Trajectories of Left Heart Geometry, Mechanics, and Oxygen Demand After Bariatric Surgery. Circ Heart Fail. 2025 May;18(5):e012367. doi: 10.1161/CIRCHEARTFAILURE.124.012367. Epub 2025 Apr 7.
- Derived from this study: PubMed 38273044Grymyr LMD, Mellgren G, McCann A, Gerdts E, Meyer K, Nadirpour S, Ferno J, Nedrebo BG, Cramariuc D. Preoperative risk factors associated with left ventricular dysfunction after bariatric surgery. Sci Rep. 2024 Jan 25;14(1):2173. doi: 10.1038/s41598-024-52623-1.
- Derived from this study: PubMed 35919265Grymyr LMD, Nadirpour S, Gerdts E, Nedrebo BG, Hjertaas JJ, Matre K, Cramariuc D. One-year impact of bariatric surgery on left ventricular mechanics: results from the prospective FatWest study. Eur Heart J Open. 2021 Aug 20;1(2):oeab024. doi: 10.1093/ehjopen/oeab024. eCollection 2021 Sep.
- Derived from this study: PubMed 33257189Grymyr LMD, Nadirpour S, Gerdts E, Nedrebo BG, Hjertaas JJ, Matre K, Cramariuc D. Left ventricular myocardial oxygen demand and subclinical dysfunction in patients with severe obesity referred for bariatric surgery. Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):666-674. doi: 10.1016/j.numecd.2020.10.009. Epub 2020 Oct 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Weight Loss and Diabetes Mellitus, run by Helse Fonna at 1 site 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 3 inclusion and 1 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 2 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 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?
weight loss (time frame: From 1 year and up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01533142, which also lists 4 linked publications.
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 2 Jun 2026.