Clinical trial NCT03399097: Characterizing the Intestinal Hormonal Secretion in Non-obese, Obese and Non-obese Patients After Bariatric Surgery
Official title: Characterizing the Intestinal Hormonal Secretion in Non-obese, Obese and Non-obese Patients After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Keywords: Obesity
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Hadassah Medical Organization
First posted: 2018-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that are referred for screening colonoscopy in the gastroenterology department.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Characterization the composition of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.
timeFrame: 3 years
Secondary outcomes:
measure: Characterization the secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.
timeFrame: 4 YEARS.
Other outcomes:
measure: Characterization the secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.
timeFrame: 4 years
measure: Characterization the location of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.
timeFrame: 4 years.
Locations:
city: Tel HaShomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Amir Tirosh, MD, PhD
role: STUDY_DIRECTOR
References: