Obesity, Morbid Clinical Trial
Official title:
Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle
| NCT number | NCT02085369 |
| Other study ID # | PH2014 |
| Secondary ID | PH2014 |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2014 |
| Est. completion date | December 2023 |
| Verified date | March 2021 |
| Source | Uppsala University |
| Contact | Magnus Sundbom, MD |
| magnus.sundbom[@]akademiska.se | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Obesity bariatric surgery patients usually lose more than 50% of their former obesity within a relatively short time (~ 2 years). There is still a lack of knowledge about underlying psychological and biological mechanisms of decline in body weight. The intention of this project is to investigate whether bariatric surgery is associated with patients' cognitive ability, lifestyle and/or gene expression and metabolomics.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 2023 |
| Est. primary completion date | December 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - First bariatric surgery Exclusion Criteria: - More than one surgery |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Uppsala University Hospital | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| Uppsala University | Uppsala University Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in gene expression profile (a.o. FTO, BDNF) following a standardized meal (before vs. after surgery) | Gene expression profiling (whole genome analysis, with first interest in FTO and BDNF expression) to assess changes in gene expression before vs. after surgery, and to associate gene expression with weight loss after surgery | 1 year | |
| Secondary | The effect of bariatric surgery on cognitive functioning (inhibitory control, selective attention) | No-Go go task (to assess inhibitory control) and Stroop tasks (to assess selective attention) will be measured to assess change in these cognitive functions before vs. after surgery, and to associate cognitive functioning with weight loss after surgery | Measures 1 y, 2 y, and 5 y after surgery. |
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