NCT00755729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2008

Completed
Last Updated

September 19, 2008

Status Verified

September 1, 2008

Enrollment Period

4 months

First QC Date

September 18, 2008

Last Update Submit

September 18, 2008

Conditions

Colorectal Disease

Keywords

Preoperative oral carbohydrateInsulin resistancephosphatidylinositol-3-kinase

Outcome Measures

Primary Outcomes (1)

  • PTK activity and PI3K, PKB, GLUT4 expression in rectus abdominis muscle samples by the end of operation

    1 month (postoperative period)

Secondary Outcomes (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

    Perioperative period

Study Arms (2)

OCH

EXPERIMENTAL

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

FSD

NO INTERVENTION

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

Dietary Supplement: Preoperative Oral Carbohydrate

Interventions

Preoperative Oral CarbohydrateDIETARY_SUPPLEMENT

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

OCH

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General Surgery, Shanghai Chang Zheng Hospital,

Shanghai, Shanghai Municipality, 200003, China

Location

Related Publications (1)

  • 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. doi: 10.1002/bjs.6963.

    PMID: 20101593DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Qiang Wang, MD

    Shanghai Chang Zheng Hospital

    STUDY CHAIR

  • Zhi Guo Wang, MD

    Department of General Surgery, Shanghai Chang Zheng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2008

First Posted

September 19, 2008

Study Start

November 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

September 19, 2008

Record last verified: 2008-09

Locations

CN(1)