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

NCT03399097 | Withdrawn

• 1 other identifier: 3830-17-SMC
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Characterization the secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.

  4 YEARS.

Other Outcomes (2)

• Characterization the secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.

  4 years

• Characterization the location of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.

  4 years.

Study Arms (3)

non-obese

non-obese

obese

obese

previously obese

previously obese

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that are referred for screening colonoscopy in the gastroenterology department.

You may qualify if:

• \>18 years
• BMI\>= 35 or BMI\<=25 or 6-12 months after RYGB surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Ofir Harnoy MD: lead
• Hadassah Medical Organization: collaborator

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

RNA

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amir Tirosh, MD, PhD

  Sheba Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 16, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: July 16, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-07

Locations

IL (1)