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Clinical Trials/NCT02330263
NCT02330263CompletedNot Applicable

Effect of Preoperative Oral Carbohydrates on Postoperative Insulin Resistance in Patients Undergoing OPCAB(Off- Pump Coronary Artery Bypass Surgery)

Yonsei University2 sites in 1 country57 target enrollmentStarted: January 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
57
Locations
2
Primary Endpoint
postoperative insulin resistance
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Surgical stress creates a state of insulin resistance which has been related to increased postoperative complications. Fasting before surgery induces a catabolic state that contributes to the development of insulin resistance. The aim of this study is to evaluate the effect of preoperative oral carbohydrates on postoperative insulin resistance in patients undergoing OPCAB (off-pump coronary artery bypass surgery). Sixty patients, aged 20 to 79 years, scheduled for OPCAB will be divided into carbohydrate (n=30) and control (n=30) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage in the evening before surgery and in the morning of the operation day (3 hours before their scheduled operation). In contrast, patients in the control group consume no food or drink after midnight before their surgery. The primary endpoints are postoperative insulin resistance measured by short insulin tolerance test.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
20 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •patients who are scheduled to undergo OPCAB

Exclusion Criteria

  • •Subjects are ineligible if they have DM(Diabetes Mellitus),
  • •Gastroesophageal reflux disease or gastric emptying disorder,
  • •inflammatory bowel disease,
  • •previous treatment for intra-abdominal cancer,
  • •entered surgery more than 5 hours after ingestion of the morning carbohydrate beverage,
  • •cognitive dysfunction,
  • •disabling mental change disorder,
  • •are unable to communicate or speak Korean

Outcomes

Primary Outcomes

postoperative insulin resistance

Time Frame: within 1 hour after surgery

Secondary Outcomes

  • preoperative discomfort(24 hours)
  • perioperative hemodynamic effect(24 hours)
  • postoperative complications(24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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Effect of Preoperative Oral Carbohydrates... | Clinical Trial