Identification of Nutrient Receptors Gastrointestinal Tract

January 30, 2014 updated by: Maastricht University Medical Center

The Identification and Spatial Distribution of Different Nutrient Receptors Along the Gastrointestinal (GI) Tract

Investigating which receptors are involved in nutient sensing of enteroendocrine cells and on nerve endings, gives further knowledge on the kind of nutrients responsible for the secretion of gut hormones involved in satiety signalling. So far only little is know about the distribution of potential nutient sensing receptors along the gastrointestinal tract. The investigators are interested in the intestinal parts which highly secrete CCK and GLP-1. By comparing these tissues, it is expected to further elucidate which receptors are important for satiety signalling in the intestine.

Having this information gives rise to further reseach on how these receptors stimulate the secretion of gut hormones. Moreover, knowing which receptors are involved in satiety signalling, gives oppertunity for targeting these receptors to increase satiety and influencing food intake.

The investigators aim to investigate the distribution of the above mentioned receptors, in the following referred to as 'nutrient sensing receptors', which have been suggested to be involved in satiety signalling, throughout the intestinal tract. For these receptors the gene expression, localisation and protein expression will be determined at different locations. This will be measured in intestinal mucosal biopsies of two locations in the duodenum, in the terminal ileum, the ascending colon, the transverse colon and the descending colon.

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

No

Genders Eligible for Study

All

Description

Inclusion criteria for duodenal biopsies:

  • Step 1 (patients asked for participation):

    1. Patients (male and female between 18 and 65 years) referred for upper GI endoscopy (because of functional complaints)
    2. Based on medical history and previous examination, no objection arises for taking extra biopsies during the gastroduodenoscopy.
  • Step 2 (patients agreed to participate and in whom biopsies will be taken) 1) Patients with no relevant endoscopic abnormalities (gastroduodenoscopy): patients without gastric or duodenal ulcers/polyps/lesions suspect for malignancy and esophageal lesions or varices.

Inclusion criteria for ileal and colon biopsies:

  • Step 1 (patients asked for participation):

Patients (male and female between 18 and 65 years) referred for colonoscopy (because of screening for colorectal cancer or follow up of colonic polyps) Based on medical history and previous examination, no objection arises for taking extra biopsies during the colonoscopy

  • Step 2 (patients agreed to participate and in whom biopsies will be taken) Patients with no relevant endoscopic abnormalities (colonoscopy): patients without ileal and/or colonic ulcers/polyps/diverticula and lesions suspect for malignancy Ileum can be reached during colonoscopy

Exclusion criteria for duodenal and ileal colon biopsies:

  1. History of severe cardiovascular, gastrointestinal/ hepatic, hematological/immunologic, metabolic/nutritional disease and/or laboratory assessments which might limit participation in the study. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
  2. Use of medication, which could interfere with normal coagulation (anticoagulants, antiplatelet drugs).
  3. Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
  4. Excessive alcohol consumption (>20 alcoholic consumptions per week)

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Biopsies
Intestinal biopsies were taken in patients who underwent endoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurements of the expression of receptors with quantitative reverse transcription polymerase chain reaction (q-PCR) in mucosal biopsies of the duodenum, terminal ileum and colon.
Time Frame: 1 day
Measurements of the expression of receptors with quantitative reverse transcription polymerase chain reaction (q-PCR) in mucosal biopsies of the duodenum, terminal ileum and colon.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurements of the location of the receptors with immunohistological techniques in mucosal biopsies of the duodenum, terminal ileum and colon.
Time Frame: 1 day
Measurements of the location of the receptors with immunohistological techniques in mucosal biopsies of the duodenum, terminal ileum and colon.
1 day
Measurements of protein expression in mucosal biopsies of the duodenum, terminal ileum and colon.
Time Frame: 1 day
Measurements of protein expression in mucosal biopsies of the duodenum, terminal ileum and colon.
1 day

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Prof Masclee, MD,PhD, Maastricht University Medical Center

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

May 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • NL39168.068.12

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 Taking intestinal biopsies

Subscribe