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Investigation of underlying metabolic mechanisms and impact on the two surgical procedures on inflammatory factors.
The aim of this project is to investigate underlying metabolic mechanisms in a subpopulation of patients of the SLIM trial, where a laparoscopic proximal Roux-en-Y gastric bypass (LRYGB) with a longer biliopancreatic limb (BPL) is compared to a standard LRYGB. For this purpose, the aim is to examine differences in number of intestinal enteroendocrine cells, subpopulations of intestinal macrophages, and gene expression or DNA-methylation in tissue samples obtained by colonoscopy from the ileum and transverse colon. In addition, gut microbiota (from colon biopsy and fecal samples), meal-stimulated gut hormone profiles, glycemic control, and metabolite patterns (metabolomics; in blood, urine, stool and breath) including plasma bile acid concentrations preoperatively and 6 months post-surgery will be examined. Body composition (fat mass and lean mass) will be measured by means of BIA (bioimpedance analysis; Biacorpus).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long Biliopancreatic Limb LRYGB | Active Comparator | 25 morbidly obese patients undergoing gastric bypass surgery, participating in SLIM Trial. |
|
| Short Biliopancreatic Limb LRYGB | Active Comparator | 25 morbidly obese patients undergoing gastric bypass surgery, participating in SLIM Trial. |
|
| Control | No Intervention | 15 normal weight control group without surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long Biliopancreatic Limb LRYGB | Procedure | LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose tolerance | Change in glucose tolerance as measured by plasma glucose concentrations at 120 minutes after ingestion of a standardized liquid test meal, pre-OP and 6-8 months post-OP. | pre-OP and 6-8 months post-OP |
| Measure | Description | Time Frame |
|---|---|---|
| glycemic control | Change in glucose variability measured by continuous glucose measurement over 1 week, pre-OP and 6-8 months post-OP. | pre-OP and 6-8 months post-OP |
| intestinal glucose absorption rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Christin Meyer-Gerspach, PD Dr. phil. II Dr. habil. | St. Clara Forschung AG / St. Claraspital AG | Principal Investigator |
| Bettina Wölnerhanssen, PD Dr. med. | St. Clara Forschung AG / St. Claraspital AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Clara Research Ltd, St Claraspital Basel | Basel | 4002 | Switzerland |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Short Biliopancreatic Limb LRYGB | Procedure | Standard LRYGB with a 80 cm BPL and a 180 cm long AL. |
|
Differences in intestinal glucose absorption rate after ingestion of a standardized liquid test meal measured by 3-OMG
| pre-OP and 6-8 months post-OP |
| gastrointestinal peptides | Differences in the release of gastrointestinal peptides after ingestion of a standardized liquid test meal | pre-OP and 6-8 months post-OP |
| intestinal enteroendocrine cells | Differences in number and phenotype (protein expression) of intestinal enteroendocrine cells (from ileum biopsies) | pre-OP and 6-8 months post-OP |
| intestinal macrophages | Differences in the number and phenotype (gene expression, methylation) of intestinal macrophages and subpopulations (from colon biopsies) | pre-OP and 6-8 months post-OP |
| gut microbiota composition | Differences in gut microbiota composition (from colon biopsy and fecal sample) | pre-OP and 6-8 months post-OP |
| bile acids | Differences in bile acids and metabolomic patterns (blood) | pre-OP and 6-8 months post-OP |
| inflammatory profile | Differences in inflammatory profile measured by hsCRP in blood | pre-OP and 6-8 months post-OP |
| enterocyte gene expression | Differences in enterocyte gene expression or DNA-methylation (tissue samples from ileum biopsies) | pre-OP and 6-8 months post-OP |
| appetite-related sensations | Differences in subjective appetite-related sensations (feelings of hunger, prospective food consumption, satiation and fullness) after liquid test meal, assessed with Visual Analog Scales | pre-OP and 6-8 months post-OP |
| body composition | Body composition (measured by Bio Impedance Analysis (BIA)) | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 1 | Differences in mineral metabolism parameter (creatinine) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 2 | Differences in mineral metabolism parameter (phosphate) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 3 | Differences in mineral metabolism parameter (calcium) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 4 | Differences in mineral metabolism parameter (magnesium) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 5 | Differences in mineral metabolism parameter (parathyroid hormone) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 6 | Differences in mineral metabolism parameter (calcidiol) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 7 | Differences in mineral metabolism parameter (calcitriol) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 8 | Differences in mineral metabolism parameter (FGF23) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 9 | Differences in mineral metabolism parameter (desoxypyridinoline) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 10 | Differences in mineral metabolism parameter (bone alkaline phosphatase (bALP)) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 11 | Differences in mineral metabolism parameter (osteocalcin) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 12 | Differences in mineral metabolism parameter (sclerostin) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 13 | Differences in mineral metabolism parameter (P1NP) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (blood) 14 | Differences in mineral metabolism parameter (CTX) in blood samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (stool) 1 | Differences in mineral metabolism parameter (phosphate) in feces samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (stool) 2 | Differences in mineral metabolism parameter (calcium) in feces samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (stool) 3 | Differences in mineral metabolism parameter (magnesium) in feces samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (urine) 1 | Differences in mineral metabolism parameter (creatinine) in urine samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (urine) 2 | Differences in mineral metabolism parameter (phosphate) in urine samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (urine) 3 | Differences in mineral metabolism parameter (calcium) in urine samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (urine) 4 | Differences in mineral metabolism parameter (magnesium) in urine samples. | pre-OP and 6-8 months post-OP |
| mineral metabolism (urine) 5 | Differences in mineral metabolism parameter (desoxypyridinoline) in urine samples. | pre-OP and 6-8 months post-OP |
| metabolomic patterns | Differences in metabolomic patterns assed in blood sample, urine sample, stool sample and exhaled breath. | pre-OP and 6-8 months post-OP |
| immune response | Differences in immune response biomarkers in blood measured by a cytokine screening assay | pre-OP and 6-8 months post-OP |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |