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Bariatric Surgery on the West Coast of Norway (Vestlandet) (FatWest)

This study is currently recruiting participants.
Verified February 2012 by Helse Fonna
Sponsor:
Collaborators:
Helse Førde
Helse-Bergen HF
Information provided by (Responsible Party):
Bjørn Gunnar Nedrebø, MD, PhD, Helse Fonna
ClinicalTrials.gov Identifier:
NCT01533142
First received: February 9, 2012
Last updated: February 11, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention
Weight Loss
Diabetes Mellitus
Urinary Incontinence
 Procedure: Bariatric surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Bariatric Surgery on the West Coast of Norway (Vestlandet): Prospective Study of Overweight People Undergoing Bariatric Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helse Fonna:

Primary Outcome Measures:
  • weight loss [ Time Frame: From 1 year and up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • remission of diabetes mellitus type 2 [ Time Frame: from 1 year up to 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma, serum, urine and biopsi from fat


Estimated Enrollment: 400
Study Start Date: February 2012
Groups/Cohorts Assigned Interventions
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

Patients will be treated with one of two bariatric procedure::

sleeve gastrectomy or gastric bypass

Procedure: Bariatric 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
Morbid obesity Procedure: Bariatric surgery

Patients will be treated with one of two bariatric procedure::

sleeve gastrectomy or gastric bypass

Procedure: Bariatric 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533142

Contacts
Contact: Bjorn Gunnar Nedrebo, MD,PhD +4792226845 bned@helse-fonna.no
Contact: Per Espen Hovde-Hansen, MD ?47 52732000

Locations
Norway
Helse-Fonna Recruiting
Haugesund, Norway, 5528
Contact: Bjorn Gunnar Nedrebo, MD, PhD     +4792226845     bned@helse-fonna.no    
Contact: Per Espen Hovde-Hansen, MD     +475273200        
Principal Investigator: Bjorn Gunnar Nedrebo, MD, Phd            
Sponsors and Collaborators
Helse Fonna
Helse Førde
Helse-Bergen HF
  More Information

No publications provided

Responsible Party: Bjørn Gunnar Nedrebø, MD, PhD, MD, PhD, Helse Fonna
ClinicalTrials.gov Identifier: NCT01533142     History of Changes
Other Study ID Numbers: 2010/3287
Study First Received: February 9, 2012
Last Updated: February 11, 2012
Health Authority: Norway:REK vest (Ethics Committee)

Keywords provided by Helse Fonna:
lipids

Additional relevant MeSH terms:
Diabetes Mellitus
Urinary Incontinence
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Body Weight Changes
Body Weight

ClinicalTrials.gov processed this record on May 21, 2013