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Plasma Determination of Glucagon-Like Peptide 2 as a Predictor of Recovery in Adults With Acute Intestinal Failure
This study is currently recruiting participants.
Verified by Imperial College London, September 2005
Sponsors and Collaborators: Imperial College London
CORE
St Mark's Hospital Foundation
Information provided by: Imperial College London
ClinicalTrials.gov Identifier: NCT00180648
  Purpose

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.


Condition
Short Bowel Syndrome

Drug Information available for: Glucagon
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Plasma Determination of Glucagon-Like Peptide 2 as a Predictor of Recovery in Adults With Acute Intestinal Failure

Further study details as provided by Imperial College London:

Estimated Enrollment: 30
Study Start Date: February 2005
Estimated Study Completion Date: February 2008
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180648

Contacts
Contact: Katharina Wallis katharina.wallis@ic.ac.uk

Locations
United Kingdom, Middlesex
St Mark's Hospital Recruiting
Harrow, Middlesex, United Kingdom, HA1 3UJ
Contact: Katharina Wallis, MD     0044 797 101 4634     katharina.wallis@ic.ac.uk    
Sub-Investigator: Katharina Wallis, MD            
Sponsors and Collaborators
Imperial College London
CORE
St Mark's Hospital Foundation
Investigators
Principal Investigator: Alastair Forbes University College London Hospitals
  More Information

Web site devoted to the study of the glucagon-like peptides  This link exits the ClinicalTrials.gov site

Study ID Numbers: 04/Q0405/83
Study First Received: September 12, 2005
Last Updated: September 12, 2005
ClinicalTrials.gov Identifier: NCT00180648  
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Short Bowel Syndrome
Intestinal Failure
Glucagon Like Peptide 2
Parenteral Nutrition

Study placed in the following topic categories:
Digestive System Diseases
Postoperative Complications
Gastrointestinal Diseases
Glucagon
Malabsorption Syndromes
Short Bowel Syndrome
Intestinal Diseases

Additional relevant MeSH terms:
Disease
Pathologic Processes
Therapeutic Uses
Syndrome
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009