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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03399097
• Other study ID #: 3830-17-SMC
• Status: Withdrawn
• Start date: December 2018
• Est. completion date: July 16, 2020

Study information

• Verified date: July 2020
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 16, 2020
• Est. primary completion date: December 2018
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel HaShomer

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Ofir Harnoy MD	Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 ELISA.	4 years
Other	Characterization the location of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.	The location of somatostatin, proglucagon and serotonin will be quantified using ELISA.	4 years.
Primary	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	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.