Diabetes Mellitus Clinical Trial
— FatWestOfficial title:
Bariatric Surgery on the West Coast of Norway (Vestlandet): Prospective Study of Overweight People Undergoing Bariatric Surgery
NCT number | NCT01533142 |
Other study ID # | 2010/3287 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | February 9, 2012 |
Last updated | February 17, 2016 |
Start date | February 2012 |
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
Status | Recruiting |
Enrollment | 400 |
Est. completion date | |
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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Norway | Helse-Fonna | Haugesund |
Lead Sponsor | Collaborator |
---|---|
Helse Fonna | Helse Førde, Helse-Bergen HF |
Norway,
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 |
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