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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
CORE
St Mark's Hospital Foundation
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00180648
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Plasma Determination of Glucagon-Like Peptide 2 as a Predictor of Recovery in Adults With Acute Intestinal Failure

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180648

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

Locations
United Kingdom
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

Additional Information:
No publications provided

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

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
Glucagon-Like Peptide 1
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins

ClinicalTrials.gov processed this record on August 28, 2014