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

Withdrawn

• Conditions: Obesity

• Registration Number: NCT03399097
• Lead Sponsor: Dr. Ofir Harnoy MD

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 Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-16
• Study Start: 2018-12
• Primary Completion: 2018-12
• Status Verified: 2020-07
• Study Completion: 2020-07-16
• Last Update Submitted: 2020-07-16
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel HaShomer, Israel