Characterizing the Intestinal Hormonal Secretion in Non-obese, Obese and Non-obese Patients After Bariatric Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Characterization the composition of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Characterization the composition of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.
Time Frame: 3 years
The number of somatostatin, proglucagon and serotonin positive cells in the terminal ileum and Colon by immunohistochemistry.
Secondary Outcomes
- Characterization the secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.(4 YEARS.)
Investigators
Dr. Ofir Harnoy MD
Principal Investigator
Sheba Medical Center