Fat Based Enteral Nutrition for Blood Glucose Control in ICU | NCT02584907

Studies
Fat Based Enteral Nutrition for Blood Glucose Control in ICU

NCT02584907

Sponsor

Shahid Beheshti University

Status

Completed

Last Update Posted

Apr 17, 2017Actual

Enrollment

88Actual

Phase

Not Applicable

Conditions

Hyperglycemia

Interventions

High Fat Enteral Nutrition

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 1, 2017Actual

First Submitted Date

Oct 19, 2015

First Submission Date that Met QC Criteria

Oct 22, 2015

First Posted Date

Oct 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2017

Last Update Posted Date

Apr 17, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zahra Vahdat Shariatpanahi, Assistant Professor, Shahid Beheshti UniversityPrincipal Investigator

Lead Sponsor

Shahid Beheshti UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this randomized, double-blind clinical trial, eligible hospitalized ICU patients with EN will be included. Patients will be divided into two groups. The control group with the standard EN and intervention group with high fat EN. 50% of the total fat will be provided by olive oil. Nutritional intake record form will be completed and daily calorie intake will be calculated. High fat EN feeding will be offered for 15 consecutive days maximally. At the end of the study mean blood glucose, duration of hospitalization and rate of infection will be compared in two groups.

Detailed Description

In this randomized, double-blind clinical trial, 88 eligible hospitalized ICU patients with EN will be included. Written consent form will be completed. Physical examination will be done by specialist and nutritional care process will be offered by an RD. Demographic, laboratory and nutritional data will be extracted and entered in prepared form. Venous blood samples will be taken and laboratory values will be measured and recorded at specified times. Patients will be divided into two groups. The control group with the standard EN (Protein; 20% carbohydrate; 50% and fat; 30% from total calories) and intervention group with high fat EN (Protein; 20% carbohydrate; 35% and fat; 45% from total calories). 50% of the total fat will be provided by olive oil. Any feeding rout such as naso - gastric , Percutaneous endoscopic gastrostomy (PEG ) or Percutaneous endoscopic jejunostomy (PEJ) with Intermittent feeding protocol will be accepted feeding method . Nutritional intake record form will be completed and daily calorie intake will be calculated. High fat EN feeding will be offered for 15 consecutive days maximally

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Fat Enteral Nutrition	Experimental	Diet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate	Other: High Fat Enteral Nutrition
Standered Enteral Nutrition	No Intervention	Diet in standard group will be 20% from protein, 30% from fat and 50% from carbohydrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High Fat Enteral Nutrition	Other	Diet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate	High Fat Enteral Nutrition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Glucose		1 year

Secondary Outcomes

Measure	Description	Time Frame
Length of Stay in ICU		1 year
Occurrence of Infection		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being on Enteral Nutrition
BS≥ 200mg/dl
Without Renal and Liver Failure
Without Hyperlipidemia and Nephrotic Syndrome
Without Infection
Without Obesity

Exclusion Criteria:

Death or Discharge before Day 7

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zahra Vahdat Shariatpanahi, MD, Ph.D	Faculty of Nutrition and Food Sciencees, Shahid Beheshti University of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Nutrition Sciences and Food Technology		Tehran			Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Wewalka M, Drolz A, Zauner C. Influence of fat-based versus glucose-based enteral nutrition formulas on glucose homeostasis. Crit Care. 2013; 17(Suppl 2): P250. Published online 2013 Mar 19. doi: 10.1186/cc12188. PMCID: PMC3642614.

ID	Term
D006943	Hyperglycemia
D016638	Critical Illness

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D020969	Disease Attributes