NCT01533142

Brief 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). 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

8 years

First QC Date

February 9, 2012

Last Update Submit

May 30, 2026

Conditions

Weight LossDiabetes MellitusUrinary Incontinence

Keywords

lipids

Outcome Measures

Primary Outcomes (1)

  • weight loss

    From 1 year and up to 5 years

Secondary Outcomes (1)

  • remission of diabetes mellitus type 2

    from 1 year up to 5 years

Study Arms (2)

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

Procedure: Bariatric surgery

Morbid obesity

Procedure: Bariatric surgery

Interventions

Bariatric surgeryPROCEDURE

Patients will be treated with one of two bariatric procedure:: sleeve gastrectomy or gastric bypass

Morbid obesitysurgical methods

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Both sexes 18-60 years old Patients with morbid obesity that is applied to the bariatric surgery. Signed informed consent

You may qualify if:

  • Both sexes 18-60 years old
  • Patients with morbid obesity that is applied to the bariatric surgery.
  • Signed informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helse-Fonna

Haugesund, Haugesund, 5528, Norway

Location

Related Publications (4)

  • 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.

    PMID: 40190274DERIVED

  • Grymyr 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.

    PMID: 38273044DERIVED

  • Grymyr 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.

    PMID: 35919265DERIVED

  • Grymyr 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.

    PMID: 33257189DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, urine and biopsi from fat

MeSH Terms

Conditions

Weight LossDiabetes MellitusUrinary Incontinence

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological Manifestations

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 9, 2012

First Posted

February 15, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

June 2, 2026

Record last verified: 2026-05

Locations

NO(1)