Refeeding SyndromeNCT01227850
Leptin, IGF1 and the Refeeding Index
An observational study of Refeeding Syndrome, run by King's College Hospital NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refeeding Syndrome
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients referred for parenteral nutrition at King's College Hospital between January and April 2009.
Who cannot join
- Non adult patients (less than 18 years of age).
About this study
Official title: Leptin and IGF1; Diagnostic Markers of Refeeding Syndrome and Mortality
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.
Read more
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.
- Conditions
- Refeeding Syndrome
- 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
- Medical subject headings
- Refeeding Syndrome, Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parenteral nutrition patients. | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refeeding SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Carel W Le Roux, MRCPath, MRCP, PhD, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227850
- Sponsor's protocol ID
- Refeedingindex0810
- Status last verified
- Oct 2010
- First submitted
- 22 Oct 2010
- Last updated
- 25 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leptin and IGF1; Diagnostic Markers of Refeeding Syndrome and Mortality
- ClinicalTrials.gov ID
- NCT01227850
- Acronym / sponsor ID
- Refeedingindex0810
- Conditions
- Refeeding Syndrome
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- First posted
- 25 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parenteral nutrition patients. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients referred for parenteral nutrition at King's College Hospital between January and April 2009.
Key exclusion criteria (1 listed)
- Non adult patients (less than 18 years of age).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2010.
- Derived from this study: PubMed 24609720Goyale 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.
Related trials for Refeeding Syndrome
Not yet recruitingObservational study
Respiratory Quotient and Phosphate Changes During Early Critical Illness
Refeeding Syndrome, Critical Illness
Not yet recruitingObservational study
3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study
Anorexia in Adolescence, Anorexia Nervosa
Not yet recruitingObservational study
Gastrointestinal Hormones and Metabolomic Profiling Following Mixed-Meal Tolerance Tests in Patients at Risk of Refeeding Syndrome
Refeeding Syndrome, Malnutrition
Active, not recruitingPhase 1
Slow Introduction of Nutrition for Ill Malnourished Children
Malnutrition, Severe Acute, Malnutrition, Child
Recruiting
Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome
Critical Illness, Malnutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carel W Le Roux, MRCPath, MRCP, PhD principal investigator
King's College Hospital NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Refeeding Syndrome, run by King's College Hospital NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01227850, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2010; AzTrials last refreshed its copy on 28 Oct 2026.