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Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance

Primary Purpose

Insulin Resistance

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Preoperative Oral Carbohydrate Drink
Sponsored by
The Second Affiliated Hospital of Dalian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance focused on measuring Insulin resistance, Diabetes mellitus, Carbohydrate

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients underwent elective open colorectal resection for colorectal carcinoma and electric orthopedic surgery

Exclusion Criteria:

  • Weight loss greater than 10 per cent during the previous 6 months
  • Renal insufficiency (creatinine, > 3 mg/dl; hemodialysis)
  • Hepatic insufficiency (Child-Pugh class, ≥ B)
  • Gastro-oesophageal reflux disease
  • Gastrointestinal obstruction or conditions (including pharmacological treatment) known to affect gastric emptying rate

Sites / Locations

  • The Second Hospital of Dalian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oral carbohydrate

Fasting

Arm Description

fast from midnight the night before surgery, and patients consume 400 ml Preoperative oral carbohydrate preOp®(12.5% carbohydrates, 0.5%kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, the Netherlands) 3 hours prior to induction of anesthesia and finished the ingestion within 20 minutes.

fast from midnight the night before surgery, and no preoperative oral carbohydrate loading

Outcomes

Primary Outcome Measures

VAS
Preoperative general well-beings before assessed with the visual analogue scale (VAS).

Secondary Outcome Measures

HOMA
Preoperative insulin resistance before and immediately after the surgery assessed with the homeostasis model assessment (HOMA)

Full Information

First Posted
May 19, 2018
Last Updated
October 8, 2018
Sponsor
The Second Affiliated Hospital of Dalian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03658564
Brief Title
Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance
Official Title
Preoperative Oral Carbohydrate Treatment in Diabetes Patients: A Randomized, Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2018 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Dalian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Insulin resistance is a positive protective reaction against surgery .this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Recently several clinical studies have shown that a carbohydrate-rich drink given 2 h before surgery diminishes postoperative insulin resistance in patient. The aim of our study is to investigate the influence on insulin resistance in patient with diabetes.
Detailed Description
Insulin resistance is a positive protective reaction against surgery . As a response to surgery, activation of neuroendocrine and inflammation systems occurs as a protective reaction. However, this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Recently several clinical studies have shown that a carbohydrate-rich drink given 2 h before surgery diminishes postoperative insulin resistance in patient. The aim of our study is to investigate the influence on insulin resistance in patient with diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Insulin resistance, Diabetes mellitus, Carbohydrate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral carbohydrate
Arm Type
Experimental
Arm Description
fast from midnight the night before surgery, and patients consume 400 ml Preoperative oral carbohydrate preOp®(12.5% carbohydrates, 0.5%kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, the Netherlands) 3 hours prior to induction of anesthesia and finished the ingestion within 20 minutes.
Arm Title
Fasting
Arm Type
No Intervention
Arm Description
fast from midnight the night before surgery, and no preoperative oral carbohydrate loading
Intervention Type
Dietary Supplement
Intervention Name(s)
Preoperative Oral Carbohydrate Drink
Intervention Description
Patients in Oral carbohydrate group consumed 400 ml Preoperative Oral Carbohydrate Drink Nutricia preOp® (12.5% carbohydrates, 0.5kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, the Netherlands) 3 hours prior to induction of anesthesia and finished the ingestion within 20 minutes.
Primary Outcome Measure Information:
Title
VAS
Description
Preoperative general well-beings before assessed with the visual analogue scale (VAS).
Time Frame
1 day (preoperative period)
Secondary Outcome Measure Information:
Title
HOMA
Description
Preoperative insulin resistance before and immediately after the surgery assessed with the homeostasis model assessment (HOMA)
Time Frame
perioperative period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients underwent elective open colorectal resection for colorectal carcinoma and electric orthopedic surgery Exclusion Criteria: Weight loss greater than 10 per cent during the previous 6 months Renal insufficiency (creatinine, > 3 mg/dl; hemodialysis) Hepatic insufficiency (Child-Pugh class, ≥ B) Gastro-oesophageal reflux disease Gastrointestinal obstruction or conditions (including pharmacological treatment) known to affect gastric emptying rate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yang z Xiao, MD,PhD
Phone
0866-17709873399
Email
xiaozhaoy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yang z Xiao, MD,PhD
Organizational Affiliation
0866-17709873399
Official's Role
Study Director
Facility Information:
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yang z Xiao, MD,PhD
Phone
0866-17709873399

12. IPD Sharing Statement

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Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance

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