Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03033667

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

Comparative study between conventional fasting versus overnight infusion of lipid or carbohydrate on free fatty acids and insulin in obese patients undergoing elective first time on-pump coronary artery bypass grafting.

Condition or Disease	Intervention/Treatment	Phase
Metabolism Disorder	Dietary Supplement: G group Dietary Supplement: group L Dietary Supplement: Group C	N/A

Detailed Description

Obese patients scheduled for bypass surgery randomly assigned to three groups:

Group I (Glucose-group): patients received 500 cc of glucose 10% containing 50 g of glucose and providing patients with 200 Kcal with an osmolarity of 556 mosm/L.

Group II (Lipid-group): patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with an osmolarity of 380 mosm/L.

Group III (Control-group): patients fasted overnight from 11 pm till 9 am except for clear fluids which were allowed till 5 am.

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

Comparative Study Between Conventional Fasting Versus Overnight Infusion of Lipid or Carbohydrate on Free Fatty Acid and Insulin in Obese Patients Undergoing Elective First Time On-pump Coronary Artery Bypass Grafting

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glucose group (G group) patients received 500 cc of glucose 10% that containing 50 g of glucose and provides patients with 200 Kcal with 556 mosmoles/L.	Dietary Supplement: G group patients received 500 cc of glucose 10% containing 50 g of glucose proving patients with 200 Kcal with 556 mosmoles/L
Experimental: Lipid Group (L group) patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with osmolarity of 380 mosmoles /L.	Dietary Supplement: group L patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid which provided patients with 200 Kcal with osmolarity of 380 mosmoles /L. with a flow rate of infusion of 12.5 cc per hour
Experimental: Control Group (C group) patients was fasting overnight from 11 pm till 9 am except for clear fluids that was allowed till 5 am.	Dietary Supplement: Group C Over night fasting with no supplementation

Arm

Intervention/Treatment

Experimental: Glucose group (G group)

patients received 500 cc of glucose 10% that containing 50 g of glucose and provides patients with 200 Kcal with 556 mosmoles/L.

Dietary Supplement: G group

patients received 500 cc of glucose 10% containing 50 g of glucose proving patients with 200 Kcal with 556 mosmoles/L

Experimental: Lipid Group (L group)

patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with osmolarity of 380 mosmoles /L.

Dietary Supplement: group L

patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid which provided patients with 200 Kcal with osmolarity of 380 mosmoles /L. with a flow rate of infusion of 12.5 cc per hour

Experimental: Control Group (C group)

patients was fasting overnight from 11 pm till 9 am except for clear fluids that was allowed till 5 am.

Dietary Supplement: Group C

Over night fasting with no supplementation

Outcome Measures

Primary Outcome Measures

The change in free fatty acids levels and insulin blood levels before and after the infusion of study solution [Over an infusion period of 10 hours preoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients (> 18 years) with American Society of Anesthesia (ASA) class II-III, BMI 30-40, and New York Heart Association (NYHA) functional capacities I-II, undergoing elective on-pump coronary artery bypass grafting (CABG) using cardiopulmonary bypass (CPB).

All patients were type 1a World Health Organisation (WHO)/Fredrickson classification of primary hyperlipidemias.

Exclusion Criteria:

Patients with diabetes mellitus
Patients on fibrates
Patients type 1,2b,3,4 and 5 WHO/Fredrickson classification of primary hyperperlipidemias
Patients with history of allergic reactions to fish, egg yolk containing foods peanut or soy products
Patients with carbohydrate or fat intolerance

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hisham Hosny, assistant professor, Cairo University

ClinicalTrials.gov Identifier:

NCT03033667

Other Study ID Numbers:

SMOF

First Posted:

Jan 27, 2017

Last Update Posted:

Jan 27, 2017

Last Verified:

Jan 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Hisham Hosny, assistant professor, Cairo University

perioperative fasting

free fatty acids

coronary bypass grfting

Additional relevant MeSH terms:

Metabolic Diseases

Study Results

No Results Posted as of Jan 27, 2017