Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
28/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S Lewis

ORCID ID

Contact details

level 09
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0185146353

Study information

Scientific title

Acronym

Study hypothesis

Does feeding surgical patients improve intestinal permeability and insulin resistance?
The purpose of this study is to examine the effect of maintaining patients nutritional intake in the pre and postoperative period on insulin resistance, nitrogen turnover and intestinal permeability.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery

Intervention

The day before the operation study patients will be encouraged to take clear liquid dietary supplements during the day before their operation and on the day of their operation. Patients in group A will receive a placebo supplement of flavoured water. Patients in groups B and C will receive Fortisip. The amount of supplements will be measured to meet the patients calculated daily energy requirement. On the operative day patients will take 200ml of supplement drink at 8am then another 200ml 4 hours before their operations. In the postoperative period patient will be encouraged to take the liquid supplements as tolerated from the period immediately after their operation until normal diet is resumed. Patients in groups A and B will receive placebo supplement drinks whilst those in group C will receive Fortijuice. Insulin resistance will be measured using the HOMA method and by using a short insulin tolerance test. Intestinal permeability will be measured using a duel sugar test.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

12/09/2002

Overall trial end date

09/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

60 participants in total - 40 experimental group, 20 control.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

<18 years, diabetic, pregnant or lactating, receiving tube delivered nutrition, participating in another study.

Recruitment start date

12/09/2002

Recruitment end date

09/02/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

level 09
Plymouth
PL6 8DH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Plymouth Hospitals NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20211036

Publication citations

  1. Results

    Lidder P, Flanagan D, Fleming S, Russell M, Morgan N, Wheatley T, Rahamin J, Shaw S, Lewis S, Combining enteral with parenteral nutrition to improve postoperative glucose control., Br. J. Nutr., 2010, 103, 11, 1635-1641, doi: 10.1017/S0007114509993631.

Additional files

Editorial Notes