NCT01233726

Effects of a Complete Diet in Critically Ill Patients With Stress Hyperglycemia

Effects of a Complete Diet Rich in Monounsaturated Fatty Acids and Slow Absorption Carbohydrate Administration in Critically Ill Patients With Stress Hyperglycemia. Open Study, Blind Randomised, Multicenter and Controlled.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Vegenat, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the beneficial effects of the administration of a complete diet rich in monounsaturated fatty acids (MUFA) and slow absorption carbohydrate in patients with stress hyperglycemia(T-Diet Plus Diabet IR). The main objective of this project is to evaluate blood glucose metabolic control, insulin requirements, insulin action resistance, lipid profile and to reduce infectious complications on mechanical ventilation ICU (intensive care unit) patients after the administration of a complete diet enriched in MUFA and slow absorption carbohydrates, without fructose.

Detailed description

Enteral formula administration designed for critically ill patients in metabolic stress situations, hyperglycemia and insulin resistance, formulated with monounsaturated fatty acids (MUFA), slowly absorption carbohydrates, omega-3 series polyunsaturated fatty acids (PUFA)enriched in eicosapentanoic acid (EPA) and docosahexaenoic acid (DHA), should be associated with an improvement in metabolic control, based on glucose levels reduction, and a decrease of insulin resistance infectious complications , mechanical ventilation days, ICU and hospital stay. All this against other two high protein conventional specific diets for hyperglycaemia patients.

Conditions

• Critical Illness
• Hyperglycemia
• Dietary Modification
• Metabolic Stress Hyperglycemia
• Mechanical Ventilation Complication

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	T-Diet plus Diabet IR	Group 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
DIETARY_SUPPLEMENT	ISOSOURCE PROTEIN FIBRE	Group 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
DIETARY_SUPPLEMENT	GLUCERNA SELECT	Group 3 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.

Timeline

• Start date: 2010-04-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2010-11-03
• Last updated: 2016-09-01
• Results posted: 2016-09-01

Locations

2 sites across 1 country: Spain