Clinical trial · Interventional
Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia
NCT02032953CI-TRIAL-00064799unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Insulin | Drug | — | UNRESOLVED |
| Travasol (amino acid injection) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Insulin, Travasol (35%) postop
- description
- Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid supplementation) given from start of surgery to 6 hours after, at an amount of 35% of patient's energy expenditure as measured before surgery, .
- interventionNames
- Dietary Supplement: Travasol (amino acid injection)
- Drug: Insulin
- type
- EXPERIMENTAL
- label
- Insulin, Travasol (20%) postop
- description
- Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid infusion), given from start of surgery to 6 hours after, at an amount of 20% of patient's energy expenditure as measured before surgery.
- interventionNames
- Dietary Supplement: Travasol (amino acid injection)
- Drug: Insulin
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * American Society of Anesthesiologists class\<3 * age\>18 years * colorectal surgery for non-metastatic colorectal adenocarcinoma including right and left hemicolectomy, transverse, subtotal and total colectomy sigmoid and low anterior resection * ability to give informed consent Exclusion Criteria: * BMI\>30 Kg/meter squared * confirmed diagnosis of diabetes mellitus or a HbA1c\>6.0% * significant cardiorespiratory, hepatic, renal and neurological disease * musculoskeletal or neuromuscular disease * ingestion of drugs known to affect protein, glucose and lipid metabolism (e.g. steroids) * severe anemia (hemoglobin\<10 g/dL * pregnancy * history of severe sciatica, back surgery or other conditions which contraindicate the use of epidural catheters
References
Publications (3)
- BACKGROUNDSchricker T, Meterissian S, Wykes L, Eberhart L, Lattermann R, Carli F. Postoperative protein sparing with epidural analgesia and hypocaloric dextrose. Ann Surg. 2004 Nov;240(5):916-21. doi: 10.1097/01.sla.0000143249.93856.66. PMID 15492576
- RESULTSchricker T, Wykes L, Carli F. Epidural blockade improves substrate utilization after surgery. Am J Physiol Endocrinol Metab. 2000 Sep;279(3):E646-53. doi: 10.1152/ajpendo.2000.279.3.E646. PMID 10950834
- DERIVEDBellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3. PMID 37526194