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 | — |