Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance

NCT ID: NCT03658564

Last Updated: 2018-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Oral carbohydrate

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.

Group Type EXPERIMENTAL

Preoperative Oral Carbohydrate Drink

Intervention Type DIETARY_SUPPLEMENT

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.

Fasting

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preoperative Oral Carbohydrate Drink

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yang z Xiao, MD,PhD

Role: STUDY_DIRECTOR

0866-17709873399

Locations

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The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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yang z Xiao, MD,PhD

Role: CONTACT

0866-17709873399

Facility Contacts

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yang z Xiao, MD,PhD

Role: primary

0866-17709873399

Other Identifiers

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poster2017

Identifier Type: -

Identifier Source: org_study_id

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