Plasma Determination of Glucagon-like Peptide 2 as a Predictor of Recovery in Adults With Acute Intestinal Failure

February 19, 2016 updated by: Imperial College London
The purpose of this study is to investigate the theory that the plasma level of Glucagon like peptide 2 (GLP-2) in patients with intestinal failure can predict their clinical recovery.

Study Overview

Status

Completed

Conditions

Detailed Description

When major segments of small bowel have been removed surgically, or damaged by disease, the length of the residual bowel may be inadequate to maintain overall nutrition and the net result is described as "intestinal failure".

Without medical intervention, patients with intestinal failure become malnourished and dehydrated because their remaining intestine is unable to absorb enough water, vitamins and other nutrients from the ingested food. Intravenous feeding offers life saving treatment but causes complications like infections and liver problems. It also poses enormous strain on day to day life.

Glucagon like peptide 2 (GLP-2) is a naturally occurring hormone (or chemical messenger) that is able to increase the surface area of the intestinal lining (or mucosal mass) and the absorptive efficiency of the remaining intestine.

Intestinal failure patients in whom not only parts of the small bowel but also the large bowel have had to be surgically removed have been shown to have a markedly impaired rise in GLP-2 levels following meals, in contrast to patients with a preserved large bowel who have increased levels of GLP-2 and are known to have much better functional adaptation.

From this we hypothesise that the GLP-2 level is directly related to, and could predict, clinical recovery in intestinal failure as measured by Amount of parenteral nutrition required Length of hospital stay Mortality

We also aim to compare GLP-2 levels of patients with acute intestinal failure with that of patients with chronic intestinal failure as well as healthy controls

Study Type

Observational

Enrollment (Actual)

30

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Intestinal failure patients at St Mark's hospital

Description

Inclusion Criteria:

  • Men and woman, aged 18 years of age or older at the time of signing the informed consent form.
  • Referral to or direct admission to St. Mark's Hospital.
  • Acute intestinal failure resulting in TPN dependency as a result of major intestinal resection performed during admission to St. Mark's or at the referring hospital.

Exclusion Criteria:

  • Inability to give consent or comply with the study.
  • Inability to take test meal (unable to be tested)
  • Severe renal impairment (interference with GLP-2 excretion)
  • Severe uncorrected anaemia (preventing additional blood-letting)
  • Uncontrolled diabetes mellitus (risk of hyperglycaemia)

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

Collaborators and Investigators

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

Sponsor

Imperial College London

Collaborators

St Mark's Hospital Foundation
CORE

Investigators

  • Principal Investigator: Alastair Forbes, University College London Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

February 1, 2005

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 16, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 19, 2016

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/Q0405/83

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.

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