Characterizing the Intestinal Hormonal Secretion in Non-obese, Obese and Non-obese Patients After Bariatric Surgery

Study Overview
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Brief Summary
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The enteroendocrine system is composed from different cells along the different parts of the gastrointestinal tract, secreting diverse hormones and bariatric surgery alters intestinal hormone secretion, affecting glycemic control and weight. The aim of the study is to characterize the composition and secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post bariatric surgery.

Detailed Description
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Obesity and Diabetes Mellitus (DM) impose a significant burden of morbidity on many individuals around the world. In recent years, the enteroendocrine cells system with its diverse hormones (Glucagon, GLP-1, GIP and others) was increasingly recognized as a key player in obesity and DM homeostasis. Bariatric surgery induces weight loss as well as an improvement in glycemic control often leading to diabetes reversal and occasionally to postprandial hypoglycemic events. The aim of the study is to characterize the composition and secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post bariatric surgery.

Official Title
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Characterizing the Intestinal Hormonal Secretion in Non-obese, Obese and Non-obese Patients After Bariatric Surgery

Conditions
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Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years BMI>= 35 or BMI<=25 or 6-12 months after RYGB surgery Exclusion Criteria: Known HIV infection Any NSAID'S usage in the last 3 months Known Celiac disease Concomitant disease with potential small bowel or colonic involvement (Tb, sarcoidosis, IBD, microscopic colitis etc') Pregnancy Participation in another clinical trial Any use of medications known to modulate glucagon levels such as GLP1 analogs, DPP4 inhibitors and/or SGLT2 inhibitors. Insulin-treated patients. Declined to sign an informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-obese<br>non-obese | |
| obese<br>obese | |
| previously obese<br>previously obese | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization the composition of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery. | The number of somatostatin, proglucagon and serotonin positive cells in the terminal ileum and Colon by immunohistochemistry. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization the secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery. | Total hormonal content of somatostatin, proglucagon and serotonin will be quantified using mRNA level qunatitation | 4 YEARS. | 

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