Enteroendocrine Cells Before and After Sleeve Gastrectomy

NCT ID: NCT02589587

Last Updated: 2016-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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).

Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

sleeve gastrectomy

Intervention Type PROCEDURE

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

no intervention

Lean, healthy controls will undergo endoscopy and biopsies will be taken from stomach and duodenum.

Group Type OTHER

no intervention

Intervention Type OTHER

lean control group

Interventions

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sleeve gastrectomy

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

Intervention Type PROCEDURE

no intervention

lean control group

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Beglinger, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EEC

Identifier Type: -

Identifier Source: org_study_id

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