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

This study has been completed.
Sponsor:
Information provided by:
Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:
NCT00755729
First received: September 18, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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 4

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:


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

  Show Detailed Description

  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
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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):
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 July 29, 2014