Insulin Therapy Reduce Post-Operative Inflammatory Response After Curative Colorectal Cancer Resection: Randomization Controlled Trial
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ClinicalTrials.gov Identifier: NCT02746432 |
Recruitment Status : Unknown
Verified August 2017 by Mazen Hassanain, King Saud University.
Recruitment status was: Not yet recruiting
First Posted : April 21, 2016
Last Update Posted : August 22, 2017
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Research Problem:
Surgical stress induces inflammation and postoperative immuno-suppression, which are risk.
factors for both post-operative complication and possible disease recurrence. Colorectal cancer is in the top 5 malignancies in the Kingdome and the highest incidence in males. Recurrent disease locally or distally occurs in 35% of patients and is the leading cause of death in these patients. Despite the new era of laparoscopic surgery, still surgical stress is present and equally traumatic to the conventional open colorectal resection, earlier studies showed no major differences in post-operative inflammatory and immunological reactions. The previous studies revealed the anti-inflammatory effects of the hyper-insulinimic euglycemic therapy. Benefits observed in both major liver resection and in cardiac surgery. The anti-inflammatory effect reduced the surgical stress and postoperative inflammation.
The hypothesis is "Can intraoperative hyper-insulinimic euglycemic infusion reduce post operative inflammation and immunomodulation in colon cancer patients undergoing a curative surgery?"
Research methodology Triple blinded randomized controlled study with estimated sample size of 144 patients of non-metastatic colorectal cancer patients operated at King Saud University Medical city with a confirmed diagnosis of colon adenocarcinoma. Patients Consented will undergo computer randomization to receive intraoperative hyper-insulinimic normoglycemic infusion (experimental) or standardized insulin sliding scale and saline (control). A common preoperative and postoperative pathway with standardized management and pain control in both groups.
Outcomes will be measured via a battery of laboratory test consist of routine labs, inflammatory markers and immunological markers to be repeated at fixed timed intervals. All patients will be followed by regularly for 5 years.
Research objectives
Primary outcomes to examine:
- The anti-inflammatory effects of intraoperative hyper-insulinimic euglycemic therapy in patients undergoing colorectal cancer surgery.
- The immunomodulatory effect of intraoperative hyper-insulinimic euglycemic infusion
Secondary outcomes:
- Thirty days post-operative morbidity.
- Overall survival rate.
- Disease-free survival rate.
Condition or disease | Intervention/treatment | Phase |
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Colon Cancer | Drug: Hyper insulinemic euglycemic clamp | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 144 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | Insulin Therapy Reduce Post-Operative Inflammatory Response After Curative Colorectal Cancer Resection: Randomization Controlled Trial |
Estimated Study Start Date : | January 1, 2018 |
Estimated Primary Completion Date : | March 2021 |
Estimated Study Completion Date : | March 2021 |

Arm | Intervention/treatment |
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No Intervention: Control group
Routine intra operative saline infusion to be administered.pre-operation and timed assessment lab set to be obtained.
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Experimental: Intervention group.Hyper insulinemic euglycemic clamp
After obtaining a baseline preoperative lab set blood glucose value, 2 U/kg bolus of insulin to be administered IV followed by an infusion of 2 U/ kg/min.fiver - Ten minutes after starting the insulin (Human regular insulin) ) infusion, and when the blood glucose is <6.1 mmol /L (110 mg /dL). an Infusion of dextrose 20% supplemented with pottasium phosphate (30 mmol/L ) to be administered. In the operating room, blood glucose levels were measured every 5-15 minutes, and the dextrose infusion rate was adjusted to maintain arterial glycemia between 3.5 and 6.1 mmol/L (63-110 mg/dL). timed intra operative lab assessment to be obtained.
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Drug: Hyper insulinemic euglycemic clamp
After obtaining a baseline preoperative lab set blood glucose value, 2 U/kg bolus of insulin (Human regular insulin) to be administered IV followed by an infusion of 2 U/ kg/min.fiver - Ten minutes after starting the insulin infusion, and when the blood glucose is <6.1 mmol /L (110 mg /dL). an Infusion of dextrose 20% supplemented with pottasium phosphate (30 mmol/L ) to be administered. In the operating room, blood glucose levels were measured every 5-15 minutes, and the dextrose infusion rate was adjusted to maintain arterial glycemia between 3.5 and 6.1 mmol/L (63-110 mg/dL). timed intra operative lab assessment to be obtained. |
- The anti-inflammatory effects of intraoperative hyper-insulinimic euglycemic therapy in patients undergoing colorectal cancer surgery. [ Time Frame: 1 month ]effect on Inflamatory profile namely levels of Tnf- Alpha , IL-8 , IL-6 , IL-10 , IL-1B,IL-18 , IFNγ, MIp1-Alpha , MMP-8 , TGF Beta , CRP
- The immunomodulatory effect of intraoperative hyper-insulinimic euglycemic infusion. [ Time Frame: 1 month ]Change of CD4 , CD8 & T-cell , Quantity and activity
- Thirty days post-operative morbidity [ Time Frame: 30 days ]
- Overall survival rate [ Time Frame: 5 years ]
- Disease-free survival rate [ Time Frame: 5 years ]
- Thirty days post-operative mortality [ Time Frame: 30 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18 years
- Documented CRC by histopathology
Exclusion Criteria:
- Patient not consenting to the study or refused.
- Metastatic disease at the time of diagnosis.
- Contraindications to insulin
- Pregnancy

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): NCT02746432
Contact: Faisal A Al-Alem, MBBS SBGS | 00966506238992 | faisal.alalem@gmail.com | |
Contact: Mazen M Hassanain, MBBS FRCSC FACS PhD | +966 50 514 1090 | mhassanain@ksu.edu.sa |
Saudi Arabia | |
King Saud University Medical City | |
Riyadh, Saudi Arabia, 7805 | |
Contact: Weam S Husseim +966541480459 wshussain@ksu.edu.sa | |
Contact: Sara Aloudah +96654602288 oudahsara@gmail.com | |
Principal Investigator: Dr. Mazen M Hassanain, MBBS FRCSC FACS PhD | |
Sub-Investigator: Dr. Ahmad M Zubaidi, MBBS MSc FRCSc | |
Sub-Investigator: Dr. Khayal A Al-Khayal, MBBS FRCSC | |
Sub-Investigator: Dr. Faisal A Alalem, MBBS SBGS |
Responsible Party: | Mazen Hassanain, Assistant Professor & Counsultant HPB and transplant Surgeon, King Saud University |
ClinicalTrials.gov Identifier: | NCT02746432 |
Other Study ID Numbers: |
KSULDRCCRCMH001 |
First Posted: | April 21, 2016 Key Record Dates |
Last Update Posted: | August 22, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
CRC-Insulin |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |