Clinical trial NCT01533142: Bariatric Surgery on the West Coast of Norway (Vestlandet)
Official title: Bariatric Surgery on the West Coast of Norway (Vestlandet): Prospective Study of Overweight People Undergoing Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Weight Loss
Diabetes Mellitus
Urinary Incontinence
Keywords: lipids
Lead sponsor: Helse Fonna
Sponsor class: OTHER
Collaborators: name: Helse Forde
name: Helse-Bergen HF
First posted: 2012-02-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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

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 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.

Primary outcomes:
measure: weight loss
timeFrame: From 1 year and up to 5 years
Secondary outcomes:
measure: remission of diabetes mellitus type 2
timeFrame: from 1 year up to 5 years
Other outcomes:
Locations:
city: Haugesund
country: Norway
facility: Helse-Fonna
Study officials:
References:
citation: 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.
citation: 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.