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Leptin, IGF1 and the Refeeding Index

This study has been completed.
Sponsor:
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01227850
First received: October 22, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

Background and study hypothesis:

Refeeding syndrome is a dangerous condition which could arise if patients who have had little or no food for many days, are started on any form of feeding. The metabolic consequences of this condition could affect the heart, lungs and nervous system of the patient and cause serious imbalance in the level of salts in the body.

The available guidelines for predicting that refeeding syndrome may occur are very subjective since they depend mainly on a history which is sometimes difficult to obtain from the patient.

The main biochemical landmark that refeeding syndrome has occurred is a fall in the phosphate levels once feeding has been started. There are currently no biochemical markers that can identify patients at risk of developing refeeding syndrome.

Leptin and IGF1 are hormones which have been observed to go down if someone has had little or no food for a while. The investigators therefore hypothesized that using a combination of leptin and IGF1 values in a 'Refeeding Index' would make the latter a useful biochemical marker to predict that refeeding may occur, hence take the precautionary measures to avoid its occurrence before starting feeding.

Design: Thirty five consecutive patients referred for commencement of parenteral nutrition (PN) were included. Serum leptin and IGF1 were measured prior to starting PN. Electrolytes, liver and renal function tests were measured before and daily for one week after initiating PN. The primary outcome was a decrease in phosphate on day two or three after initiating PN. A 'Refeeding Index' (RI) was defined as leptin x IGF1 divided by 2800 to produce a ratio of 1.0 in patients who are well nourished.


Condition
Refeeding Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Leptin and IGF1; Diagnostic Markers of Refeeding Syndrome and Mortality

Further study details as provided by King's College Hospital NHS Trust:

Enrollment: 35
Groups/Cohorts
Parenteral nutrition patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to our department at King's College Hospital, for commencement of parenteral nutrition (PN).These included all ages above 18 and both sexes. Consent to commence PN was taken from the patients prior to starting it. Daily bloods were taken for routine laboratory analysis as part of the usual patient care.

Criteria

Inclusion Criteria:

  • Adult patients referred for parenteral nutrition at King's College Hospital between January and April 2009.

Exclusion Criteria:

  • Non adult patients (less than 18 years of age).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01227850

Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
Principal Investigator: Carel W Le Roux, MRCPath, MRCP, PhD King's College Hospital NHS Trust
  More Information

No publications provided

Responsible Party: Dr Carel Le Roux, King's College Hospital
ClinicalTrials.gov Identifier: NCT01227850     History of Changes
Other Study ID Numbers: Refeedingindex0810
Study First Received: October 22, 2010
Last Updated: October 22, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by King's College Hospital NHS Trust:
Leptin
IGF1
Refeeding Index
Hypophosphataemia
Primary focus of the study was to detemine whether the 'Refeeding Index', could reliably predict,that the refeeding syndrome would occur

Additional relevant MeSH terms:
Refeeding Syndrome
Syndrome
Disease
Malnutrition
Nutrition Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014