Enteroendocrine Cells Before and After Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Procedure: sleeve gastrectomy; Other: no intervention

• Registration Number: NCT02589587
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Morbidly obese patients exhibit impaired secretion of satiation hormones which may contribute to the development of obesity. Bariatric surgery is associated with weight loss and dramatic increase in the secretion of satiation hormones, but the underlying mechanism remains unknown. The investigator's goal is therefore to examine patients before and after sleeve gastrectomy and compare findings to lean controls.

Detailed Description

Morbidly obese patients exhibit impaired secretion of satiation hormones cholecystokinin (CCK), glucagon-like peptide 1 (GLP-1) and peptide YY (PYY), which may contribute to the development of obesity. Bariatric surgery is associated with weight loss and dramatic increase in the secretion of satiation hormones, but the underlying mechanism remains unknown. A better understanding of mechanisms involved will assist in development of non-invasive therapeutic strategies. The investigator's goal is therefore to examine patients before and after sleeve gastrectomy and compare findings to lean controls. Gastric and intestinal mucosa will be collected by endoscopy from morbidly obese subjects before and 3 months after sleeve gastrectomy. In Addition, lean controls will be examined. Expression of various gut peptides will be assessed by immunohistochemistry and quantitative polymerase chain reaction (PCR).

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Morbidly obese patients scheduled for sleeve gastrectomy

• BMI > 35 kg/m2
• Age: > 18-65 years Lean, healthy controls
• BMI > 18 and < 28kg/m2
• Age: >18-40 years

Exclusion Criteria

• Bleeding diathesis
• Previous surgery on the gastrointestinal tract (appendectomy acceptable)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sleeve gastrectomy	sleeve gastrectomy	Morbidly obese patients scheduled for sleeve gastrectomy will be examined by endoscopy before and 3 months after surgery. Biopsies will be taken from stomach and duodenum.
no intervention	no intervention	Lean, healthy controls will undergo endoscopy and biopsies will be taken from stomach and duodenum.

Primary Outcome Measures

Name	Time	Method
Quantification of the enteroendocrine cell population	within 3 months after surgery	Expression of enteroendocrine cell population possessing chromogranin A, ghrelin, CCK, PYY, GLP-1 and GLP-2 by immunohistochemistry and quantitative PCR.

Secondary Outcome Measures

Name	Time	Method
Determination of tissue morphology (crypt depth, villus height)	within 3 months after surgery	Morphometric analysis

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland