Weight Loss Following Gastric Bypass or Sleeve Surgery

Study Overview
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Brief Summary
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The overall aim is to study the multiple factors determining the variation of weight loss after Roux-en-Y Gastric Bypass (RYGB) and Sleeve surgery. The specific aims are to evaluate: a) what explains the large individual differences in weight loss seen after RYGB and Sleeve surgery, b) if it is possible pre-operatively to identify which patients will not obtain beneficial effects of bariatric surgery in relation to weight loss and quality of life and c) if patients in need of improved care can be identified pre- and/or early post-operatively.

Official Title
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Patient Profiling for Successful Weight Loss After Gastric Bypass or Sleeve Surgery

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Roux-en-Y gastric bypass surgery or sleeve surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients approved for bariatric surgery at Bariatric Clinic, Køge Hospital, Denmark Exclusion Criteria: Inability to comply with the study protocol

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery<br> | Procedure: Roux-en-Y gastric bypass surgery or sleeve surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic profile | Insulin, glucose, C-peptide, GIP, glucagon, TSH, thyroid hormones, vitamin D and blood lipids | 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively | 
| Physical activity |  | 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively | 
| Appetite sensation | Following a test meal with the use of visual analogue scales (VAS) | 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively | 
| Taste preferences and taste perception | Sensory tests, picture displays (all visits) and an ad libitum test meals (3 months preoperatively and 6 months postoperatively) are used to investigate changes in taste and food preferences (liking and wanting) and taste perception | 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively | 
| Mental health |  | 3 month preoperatively, 6 month postoperatively and 18 month postoperatively | 
| Social resources |  | 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively | 
| Gut microbiota |  | 1 week preoperatively, 6 month postoperatively | 
| Appetite-regulating hormones | GLP-1, PYY, leptin, ghrelin, OXM, CCK, glicentin | 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively | 
| Bile acids and fibroblast growth factors |  | 3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively | 
| Genetics |  | 3 month preoperatively | 
| Body composition | By DXA scans | 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively | 
| Cortisol | Measured in hair | 3 month preoperatively and 18 month postoperatively | 
| Neural activity in reward-processing brain centers | By functional magnetic resonance imaging (fmri) | preoperatively and 6 month postoperatively | 
| Rewarding value of food | Behavioral test | preoperatively and 6 month postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Bariatric surgery