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CompletedNCT01227850Updated Oct 25, 2010

Leptin, IGF1 and the Refeeding Index

An observational study in Refeeding Syndrome, sponsored by King's College Hospital NHS Trust. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-25.

Sponsored by King's College Hospital NHS Trust · Observational

Study type
Observational
Model
Case-only
Enrollment
35
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Refeeding Syndrome

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Keywords

  • 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
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 35 is below the median of 102 across 2,209 observational studies indexed under Syndrome.

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Lead sponsor

King's College Hospital NHS Trust is the lead sponsor of 164 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Non adult patients (less than 18 years of age).
05

Study design

Observational model
Case-only
Enrollment
35 participants (actual)

Groups and cohorts

  • Parenteral nutrition patients.
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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Goyale A, Ashley SL, Taylor DR, Elnenaei MO, Alaghband-Zadeh J, Sherwood RA, le Roux CW, Vincent RP. Predicting refeeding hypophosphataemia: insulin growth factor 1 (IGF-1) as a diagnostic biochemical marker for clinical practice. Ann Clin Biochem. 2015 Jan;52(Pt 1):82-7. doi: 10.1177/0004563214523739. Epub 2014 Mar 7. PubMed 24609720 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01227850
Lead sponsor
King's College Hospital NHS Trust
First posted
Oct 25, 2010
Last update
Oct 25, 2010

Study contacts

Carel W Le Roux, MRCPath, MRCP, PhD
principal investigator · King's College Hospital NHS Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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