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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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
-
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.