Enteroendocrine Cells Before and After Sleeve Gastrectomy
Enteroendocrine Cells in Lean Controls and Healthy Subjects Before and After Sleeve Gastrectomy
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Oct 2013
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 12, 2016
April 1, 2016
2.4 years
September 28, 2015
April 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Determination of tissue morphology (crypt depth, villus height)
within 3 months after surgery
Study Arms (2)
sleeve gastrectomy
ACTIVE COMPARATORMorbidly 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
OTHERLean, healthy controls will undergo endoscopy and biopsies will be taken from stomach and duodenum.
Interventions
Sleeve gastrectomy is an established form of bariatric (weight reducing) surgery, where the greater curvature of the stomach is removed.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Bleeding diathesis
- Previous surgery on the gastrointestinal tract (appendectomy acceptable)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Basel
Basel, CH-4031, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Beglinger, Prof.
University Hospital, Basel, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2015
First Posted
October 28, 2015
Study Start
October 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 12, 2016
Record last verified: 2016-04