Clincosm LogoSign in Get a demo

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

Sponsor
Dr. Ofir Harnoy MD (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03399097
Collaborator
Hadassah Medical Organization (Other)
0
Enrollment
1
Location
19.5
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Characterizing the Intestinal Hormonal Secretion in Non-obese, Obese and Non-obese Patients After Bariatric Surgery
    Anticipated Study Start Date :
    Dec 1, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2018
    Actual Study Completion Date :
    Jul 16, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    non-obese

    non-obese
    obese

    obese
    previously obese

    previously obese

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Other Outcome Measures

    1. 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 ELISA.

    2. Characterization the location of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery. [4 years.]

      The location of somatostatin, proglucagon and serotonin will be quantified using ELISA.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheba Medical Center Tel HaShomer Israel 52621

    Sponsors and Collaborators

    • Dr. Ofir Harnoy MD
    • Hadassah Medical Organization

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Ofir Harnoy MD, Principal Investigator, Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT03399097
    Other Study ID Numbers:
    • 3830-17-SMC
    First Posted:
    Jan 16, 2018
    Last Update Posted:
    Jul 20, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Ofir Harnoy MD, Principal Investigator, Sheba Medical Center
    Obesity
    Additional relevant MeSH terms:
    Obesity

    Study Results

    No Results Posted as of Jul 20, 2020