Bariatric Surgery on the West Coast of Norway (Vestlandet)

Diabetes Mellitus Clinical Trial

— FatWest  

Official title:

Bariatric Surgery on the West Coast of Norway (Vestlandet): Prospective Study of Overweight People Undergoing Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01533142
• Other study ID #: 2010/3287
• Status: Recruiting
• Phase: N/A
• First received: February 9, 2012
• Last updated: February 17, 2016
• Start date: February 2012

Study information

• Verified date: February 2016
• Source: Helse Fonna
• Contact: Bjorn Gunnar Nedrebo, MD,PhD
• Phone: +4792226845
• Email: bned[@]helse-fonna.no
• Is FDA regulated: No
• Health authority: Norway:REK vest (Ethics Committee)
• Study type: Observational

Clinical 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). 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Urinary Incontinence
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
Norway	Helse-Fonna	Haugesund

Sponsors (3)

Lead Sponsor	Collaborator
Helse Fonna	Helse Førde, Helse-Bergen HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss		From 1 year and up to 5 years	No
Secondary	remission of diabetes mellitus type 2		from 1 year up to 5 years	No