RecruitingACTRN12614000166673

Diabetes specific formulae versus standard formulae as enteral nutrition to treat hyperglycaemia in critically ill patients: study protocol for a randomised controlled feasibility trial

A randomised controlled feasibility trial to determine the efficacy of diabetes specific formulae to reduce exogenous insulin doses required to obtain acceptable glycaemic control when compared to the standard nutritional formula in critically ill tube fed patients

Sponsor

Mater Foundation and Mater Research Institute

Enrollment

54 participants

Start Date

Jan 30, 2015

Study Type

Interventional

Conditions

Critically ill tube fed ICU patients Hyperglycemia

Summary

This is a prospective, blinded, randomised controlled feasibility trial of critically ill tube fed ICU patients looking at the effectiveness of diabetes specific nutritional formula in managing stress hyperglycaemia. The primary aim of this study is to determine whether the administration of a diabetes specific formula, when compared to standard enteral formula, reduces insulin use over a 48 hour period. Secondary outcomes include both clinical endpoints and assessment of the feasibility of study processes to inform a potential multi-site RCT. A sub-study will also be incorporated to determine if altered carbohydrate, is associated with a change in oxidative stress markers, as well acute and chronic inflammatory biomarkers.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special tube-feeding formula designed for people with diabetes (a diabetes-specific formula, which is lower in carbohydrates) can reduce blood sugar levels and lower the amount of insulin needed, compared to a standard tube-feeding formula, in critically ill patients in the ICU. The study runs for 48 hours and the formula is given through a feeding tube. You may be eligible if: - You are 18 years of age or older - You are receiving tube feeding (enteral nutrition) as your only nutrition in the ICU - You need an insulin drip to control your blood sugar (two consecutive readings above 10 mmol/L) You may NOT be eligible if: - You are under 18 years of age - You (or your legal representative) have declined consent - Your treating doctor considers study participation to be clinically inappropriate for you Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Following consent participants will be randomised to the control (CHO 142g/L; 1.28kcal/mL), or the intervention, which is a low carbohydrate, low glycaemic index diabetes-specific formula (CHO 75g/L;

Following consent participants will be randomised to the control (CHO 142g/L; 1.28kcal/mL), or the intervention, which is a low carbohydrate, low glycaemic index diabetes-specific formula (CHO 75g/L; 1kcal/mL), Once treatment allocation has occurred, participants will remain on treatment as long as tube feeding continues in ICU or as per the treating physician. All investigators and the participant will be blinded to treatment allocation. Nutritional requirements will be calculated by providing an average of 100-125kJ/kg body weight or adjusted ideal body weight (BW / AIBW) and 1.2-1.5g protein/kg BW/AIBW as per current practice. For the purpose of a biomarker sub-study, a second intervention arm using a different low glycaemic index diabetes specific formula will be used (CHO 113g/L; 1kcal/mL). Randomisation to this arm will be ceased once blood and urine samples are available for the first 10-12 participants in each group. These samples will be collected from all patients at randomisation and 48 hours later. Once this has been achieved, randomisation will revert to control and intervention groups only. Collection of urine and blood samples for biomarker assay will also be discontinued at this point.

Locations(2)

Mater Adult Hospital - South Brisbane

QLD, Australia

Mater Private Hospital - South Brisbane

QLD, Australia

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ACTRN12614000166673

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