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. 2023 Aug 1;2023(8):CD007315. doi: 10.1002/14651858.CD007315.pub3

NCT02746432.

Methods Type of study: interventional
Allocation: randomised
Type of trial: endpoint classification: efficacy study
Intervention model: parallel assignment
Masking: quadruple (participant, care provider, investigator, outcomes assessor)
Primary purpose: treatment
Participants Conditions: colorectal cancer
Gender: both
Age groups: adult/senior
Enrolment: 144
Interventions Intervention: hyper‐insulinaemic euglycaemic clamp
Comparator: routine intraoperative saline infusion
Outcomes Primary outcomes: the anti‐inflammatory effects of intraoperative hyper‐insulinaemic euglycaemic therapy in people undergoing colorectal cancer surgery (1 month); effect on inflammatory profile, namely levels of TNF‐alpha, IL‐8, IL‐6, IL‐10, IL‐1B, IL‐18, IFNy, MIp1‐alpha, MMP‐8, TGF‐beta, CRP
Secondary outcomes: the immunomodulatory effect of intraoperative hyper‐insulinaemic euglycaemic infusion change (1 month) on CD4, CD8, T‐cell, quantity and activity
Reason for awaiting classification Unknown
Study details
Official title and purpose of study Insulin therapy reduce post‐operative inflammatory response after curative colorectal cancer resection: randomization controlled trial
Notes