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

NCT ID: NCT03399097

Last Updated: 2020-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-31

Study Completion Date

2020-07-16

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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non-obese

non-obese

No interventions assigned to this group

obese

obese

No interventions assigned to this group

previously obese

previously obese

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role collaborator

Dr. Ofir Harnoy MD

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Ofir Harnoy MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Amir Tirosh, MD, PhD

Role: STUDY_DIRECTOR

Sheba Medical Center

Locations

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Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Other Identifiers

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3830-17-SMC

Identifier Type: -

Identifier Source: org_study_id

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