The Effect of the Preoperative Oral Carbohydrate Attenuating Immediate Postoperative Insulin Resistance on PI3K Dependent Signaling Pathway - Full Text View

Sponsor:	Shanghai Changzheng Hospital
Information provided by:	Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:	NCT00755729

Purpose

The purpose of this study is to delineate the effects of preoperative oral carbohydrate on immediate postoperative insulin resistance (PIR) in patients undergoing elective open colorectal cancer resection, and to further clarify the hypotheses that preoperative oral carbohydrate treatment attenuates PIR in patients by enhancing insulin signaling to PI3K-dependent pathway.

Condition	Intervention	Phase
Colorectal Disease	Dietary Supplement: Preoperative Oral Carbohydrate	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Basic Science
Official Title:	The Effect of the Preoperative Oral Carbohydrate Attenuating Immediate Postoperative Insulin Resistance on PI3K Dependent Signaling Pathway

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Insulin Insulin beef

U.S. FDA Resources

Further study details as provided by Shanghai Changzheng Hospital:

Primary Outcome Measures:

PTK activity and PI3K, PKB, GLUT4 expression in rectus abdominis muscle samples by the end of operation [ Time Frame: 1 month (postoperative period) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Preoperative general well-beings and the insulin resistance before and immediately after surgery assessed with the visual analogue scale (VAS) and the homeostasis model assessment (HOMA) respectively [ Time Frame: Perioperative period ] [ Designated as safety issue: Yes ]

Enrollment:	32
Study Start Date:	November 2006
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: OCH fast from midnight the night before surgery, and consume 400 ml Nutricia preOp® (12.5% carbohydrates, 0.5 kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, The Netherlands) 3 hours prior to induction of anaesthesia and finished the ingestion within 1 hour	Dietary Supplement: Preoperative Oral Carbohydrate Patients in OCH group consumed 400 ml Nutricia preOp® (12.5% carbohydrates, 0.5 kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, The Netherlands) 3 hours prior to induction of anaesthesia and finished the ingestion within 1 hour
No Intervention: FSD fast from midnight the night before surgery, and no preoperative oral carbohydrate loading	Dietary Supplement: Preoperative Oral Carbohydrate Patients in FSD group were fasted from midnight the night before surgery, and no preoperative oral carbohydrate loading

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Eligibility

Ages Eligible for Study:	25 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The present study employed 32 patients, who underwent elective open colorectal resection for colorectal carcinoma

Exclusion Criteria:

Diabetes mellitus or impaired glucose tolerance
Medication affecting insulin sensitivity
Weight loss greater than 10 per cent during the previous 6 months
Signs of distant metastasis by CT scanning
Renal insufficiency (creatinine, > 3 mg/dl; hemodialysis)
Hepatic insufficiency (Child-Pugh class, ≥ B)
Gastro-oesophageal reflux disease
Gastrointestinal obstruction
Conditions (including pharmacological treatment) known to affect gastric emptying rate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755729

Locations

China, Shanghai
Department of General Surgery, Shanghai Chang Zheng Hospital,
Shanghai, Shanghai, China, 200003

Sponsors and Collaborators

Shanghai Changzheng Hospital

Investigators

Study Chair:	Qiang Wang, MD	Shanghai Chang Zheng Hospital
Principal Investigator:	Zhi Guo Wang, MD	Department of General Surgery, Shanghai Chang Zheng Hospital

More Information

No publications provided by Shanghai Changzheng Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wang ZG, Wang Q, Wang WJ, Qin HL. Randomized clinical trial to compare the effects of preoperative oral carbohydrate versus placebo on insulin resistance after colorectal surgery. Br J Surg. 2010 Mar;97(3):317-27.

Responsible Party:	Qiang Wang, MD, Shanghai Chang Zheng Hospital
ClinicalTrials.gov Identifier:	NCT00755729 History of Changes
Other Study ID Numbers:	SCZH-0809-110
Study First Received:	September 18, 2008
Last Updated:	September 18, 2008
Health Authority:	China: Ministry of Health

Keywords provided by Shanghai Changzheng Hospital:

Preoperative oral carbohydrate
Insulin resistance
phosphatidylinositol-3-kinase

Additional relevant MeSH terms:

Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012