Enteroendocrine Cells Before and After Sleeve Gastrectomy

April 11, 2016 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, CH-4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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, healthy controls will undergo endoscopy and biopsies will be taken from stomach and duodenum.
Other: no intervention
lean control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of the enteroendocrine cell population
Time Frame: 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.
within 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of tissue morphology (crypt depth, villus height)
Time Frame: within 3 months after surgery
Morphometric analysis
within 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Estimate)

April 12, 2016

Last Update Submitted That Met QC Criteria

April 11, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • EEC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on sleeve gastrectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe