Enteroendocrine Cells Before and After Sleeve Gastrectomy

Obesity Clinical Trial

Official title:

Enteroendocrine Cells in Lean Controls and Healthy Subjects Before and After Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589587
• Other study ID #: EEC
• Status: Completed
• Phase: N/A
• First received: September 28, 2015
• Last updated: April 11, 2016
• Start date: October 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• sleeve gastrectomy
Sleeve gastrectomy is an established form of bariatric (weight reducing) surgery, where the greater curvature of the stomach is removed.

Other:
• no intervention
lean control group

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of the enteroendocrine cell population	Expression of enteroendocrine cell population possessing chromogranin A, ghrelin, CCK, PYY, GLP-1 and GLP-2 by immunohistochemistry and quantitative PCR.	within 3 months after surgery	No
Secondary	Determination of tissue morphology (crypt depth, villus height)	Morphometric analysis	within 3 months after surgery	No