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

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ClinicalTrials.gov Identifier: NCT00755729
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : September 19, 2008
Sponsor:
Information provided by:
Shanghai Changzheng Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Disease Dietary Supplement: Preoperative Oral Carbohydrate Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of the Preoperative Oral Carbohydrate Attenuating Immediate Postoperative Insulin Resistance on PI3K Dependent Signaling Pathway
Study Start Date : November 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. PTK activity and PI3K, PKB, GLUT4 expression in rectus abdominis muscle samples by the end of operation [ Time Frame: 1 month (postoperative period) ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Qiang Wang, MD, Shanghai Chang Zheng Hospital
ClinicalTrials.gov Identifier: NCT00755729     History of Changes
Other Study ID Numbers: SCZH-0809-110
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008

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