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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00180648
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 22, 2016
St Mark's Hospital Foundation
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
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 or disease
Short Bowel Syndrome

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
Actual Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Plasma Determination of Glucagon-like Peptide 2 as a Predictor of Recovery in Adults With Acute Intestinal Failure
Study Start Date : February 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Intestinal failure patients at St Mark's hospital

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00180648

Sponsors and Collaborators
Imperial College London
St Mark's Hospital Foundation
Principal Investigator: Alastair Forbes University College London Hospitals

Additional Information:
Responsible Party: Imperial College London Identifier: NCT00180648     History of Changes
Other Study ID Numbers: 04/Q0405/83
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: May 2008

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

Additional relevant MeSH terms:
Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs