Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance

Insulin Resistance Clinical Trial

Official title:

Preoperative Oral Carbohydrate Treatment in Diabetes Patients: A Randomized, Double-blind Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03658564
• Other study ID #: poster2017
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2018
• Est. completion date: January 2019

Study information

• Verified date: September 2018
• Source: The Second Affiliated Hospital of Dalian Medical University
• Contact: yang z Xiao, MD,PhD
• Phone: 0866-17709873399
• Email: xiaozhaoy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	Preoperative general well-beings before assessed with the visual analogue scale (VAS).	1 day (preoperative period)
Secondary	HOMA	Preoperative insulin resistance before and immediately after the surgery assessed with the homeostasis model assessment (HOMA)	perioperative period)