Leptin, IGF1 and the Refeeding Index

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: NCT01227850
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : October 25, 2010
Information provided by:
King's College Hospital NHS Trust

Brief Summary:

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 or disease
Refeeding Syndrome

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Case-Only
Official Title: Leptin and IGF1; Diagnostic Markers of Refeeding Syndrome and Mortality

Parenteral nutrition patients.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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).

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): NCT01227850

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Carel Le Roux, King's College Hospital Identifier: NCT01227850     History of Changes
Other Study ID Numbers: Refeedingindex0810
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: October 2010

Keywords provided by King's College Hospital NHS Trust:
Refeeding Index
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
Pathologic Processes
Nutrition Disorders