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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03399097
Enrollment
0
Registered
2018-01-16
Start date
2018-12-31
Completion date
2020-07-16
Last updated
2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity

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.

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.

Interventions

None listed

Sponsors

Hadassah Medical Organization
CollaboratorOTHER
Dr. Ofir Harnoy MD
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Characterization the composition of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.3 yearsThe number of somatostatin, proglucagon and serotonin positive cells in the terminal ileum and Colon by immunohistochemistry.

Secondary

MeasureTime frameDescription
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

MeasureTime frameDescription
Characterization the secretory profile of enteroendocrine cells in the obese, non-obese and non-obese post-bariatric surgery.4 yearsTotal hormonal content of somatostatin, proglucagon and serotonin will be quantified using ELISA.
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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026