[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525798":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":22,"centralContacts":29,"locations":36,"responsibleParty":57,"collaborators":22,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":22,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":22,"enrollmentInfo":69,"targetDuration":22,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":39,"whyStopped":22,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Effect of high-dose insulin therapy on pre-operative liver function","EXPERIMENTAL","Group 1 will consist of participants scheduled for liver resection and will undergo high-dose insulin pre-operatively to determine if baseline liver function can be optimized\u002Fimproved, as measured by 99mTc-Mebrofenin HBS.",[13],"Drug: High-Dose Insulin Therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2: Effect of high-dose insulin therapy on pre-operative liver function after LVD","Group 2 will consist of participants scheduled for liver resection that require LVD. The participants in the experimental arm will receive high-dose insulin therapy after LVD.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Group 3: Effect of high-dose insulin therapy on pre-operative liver function after LVD","NO_INTERVENTION","Group 3 will consist of participants scheduled for liver resection that require LVD. The participants in the no intervention arm will not undergo intervention with high-dose insulin therapy after LVD.",null,[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":22},"DRUG","High-Dose Insulin Therapy","A baseline blood glucose value will be obtained. Two units of insulin will be administered IV if the blood glucose is \\> mmol\u002FL. An insulin infusion of 0.12 units\u002Fkg\u002Fhr will be started. Ten minutes after starting the insulin, and when the blood glucose is \\\u003C 6 mmol\u002FL, dextrose 20% supplemented with phosphate (30 mmol\u002FL) will be infused. Blood glucose levels will be measured every 15 minutes, and the dextrose infusion rate adjusted to maintain glycemic levels between 4 and 6 mmol\u002FL for a duration of 6 hours. At the end of the 6 hour period, the insulin will be stopped and the dextrose will be weaned off.",[9,15],[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Jennifer Kalil, MD","CONTACT","514-934-1934","65657","jennifer.kalil@mail.mcgill.ca",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"McGill Univeristy Health Centre","RECRUITING","Montreal","Quebec","H3A 1A1","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-73.58781,45.50884,{"lat":49,"lon":48},[52,54],{"name":31,"role":32,"phone":33,"phoneExt":53,"email":35},"76150",{"name":55,"role":56,"phone":22,"phoneExt":22,"email":22},"Dr. Peter Metrakos, MD, Surgery","PRINCIPAL_INVESTIGATOR",{"type":56,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"peter metrakos","Professor of Surgery, Program Leader - MUHC-RI Cancer Research Program","100525798","application-of-high-dose-insulin-therapy-to-improve-liver-function-and-regeneration-100525798",false,"NCT06126419","Application of High-dose Insulin Therapy to Improve Liver Function and Regeneration","Application of High-Dose Insulin Therapy Using a Hyperinsulinemic Normoglycemic Clamp to Improve Liver Function and Regeneration","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Candidate for major liver resection\n* Resectable colorectal liver metastasis\n\nExclusion Criteria:\n\n* Inability to give consent\n* Type 1 diabetes mellitus\n* Uncontrolled blood glucose levels (fasting level \\> 10 mmol\u002FL)\n* Unresectable colorectal liver metastasis\n* Extrahepatic metastatic disease that is unresectable","ALL","18 Years",{"count":70,"type":71},70,"ESTIMATED","INTERVENTIONAL",[74],"NA","The primary objective of this interventional study is determine if the future liver remnant can be optimized by improving liver function pre-operatively in patients who are scheduled for major hepatectomy. The main questions it aims to answer are:\n\n1. Does high-dose insulin therapy improve liver function in the pre-operative setting?\n2. What is the effect of high-dose insulin therapy on liver function and liver regeneration after a liver venous deprivation (LVD) procedure?\n3. What is the relationship between volume hypertrophy and function in the regenerating liver? Participants will receive a 6-hour infusion of insulin and dextrose to maintain a hyperinsulinemic-normoglycemic state in the weeks prior to planned liver surgery to assess its effect on liver function measured by 99m-Tc-Mebrofenin hepatobiliary scintigraphy.",[77,78,79],"Liver Dysfunction","Liver Metastasis Colon Cancer","Liver Regeneration",[81,82,83,84,85],"Hyperinsulinemic-Normoglycemic Clamp","High Dose Insulin Therapy","99mTc-Mebrofenin Hepatobiliary Scintigraphy","Colorectal Cancer Liver Metastasis","Liver Resection","2024-11-18",{"date":88,"type":89},"2024-11-20","ACTUAL",{"date":91,"type":89},"2023-11-08",{"date":93,"type":71},"2026-12",{"name":5,"class":6},1]