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

July 16, 2020 updated by: Dr. Ofir Harnoy MD
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.

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel HaShomer, Israel, 52621
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
non-obese
obese
previously obese

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization the secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.
Time Frame: 4 years
Total hormonal content of somatostatin, proglucagon and serotonin will be quantified using ELISA.
4 years
Characterization the location of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.
Time Frame: 4 years.
The location of somatostatin, proglucagon and serotonin will be quantified using ELISA.
4 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Ofir Harnoy MD

Collaborators

Hadassah Medical Organization

Investigators

  • Study Director: Amir Tirosh, MD, PhD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Actual)

July 16, 2020

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

January 11, 2018

First Posted (Actual)

January 16, 2018

Study Record Updates

Last Update Posted (Actual)

July 20, 2020

Last Update Submitted That Met QC Criteria

July 16, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3830-17-SMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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