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The goal of this clinical trial is to learn the effects of preoperative carbohydrate loading on perioperative blood glucose levels and insulin resistance in type 2 diabetes mellitus undergo elective surgery. The main questions it aims to answer are:
Researchers will compare the carbohydrate loading intervention to placebo (regular drinking water with zero-calorie sweetener) to see the effects of carbohydrate loading to blood glucose levels and insulin resistance (by HOMA-IR value)
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbohydrate loading (CHO) group | Active Comparator | Patient received preoperative carbohydrate loading of 200 ml Maltodextrin 12.5%, given 2 hours before the operation |
|
| Control | Placebo Comparator | Patient received preoperative regular drinking water of 200 ml with zero-calorie sweetener, given 2 hours before the operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preoperative carbohydrate loading | Other | Patients receive 200 ml drink containing Maltodextrin 12.5%, 2 hours prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Blood Glucose Level | Blood glucose sampled from vein and capillary, measured in mg/dL | Preoperative (before intervention), 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative |
| Insulin Resistance | Calculated using Homeostasis Model Assessment Insulin Resistance (HOMA-IR), obtained from measured fasting insulin (μU/ml) × fasting glucose (mmol/l) / 22.5 | preoperative and 30 minutes postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal blood glucose incidence | Blood glucose level below 60 mg/dL (hypoglycaemia) or above 200 mg/dL (hyperglycaemia) | Preoperative, 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative |
| Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUPN Cipto Mangunkusumo | Central Jakarta | Jakarta Special Capital Region | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12230794 | Background | Ljungqvist O, Nygren J, Thorell A. Modulation of post-operative insulin resistance by pre-operative carbohydrate loading. Proc Nutr Soc. 2002 Aug;61(3):329-36. doi: 10.1079/PNS2002168. | |
| Background | Weledji EP, Njong SN, Chichom A, Verla V, Assob JC, Ngowe MN. The effects of preoperative carbohydrate loading on the metabolic response to surgery in a low resource setting. Int J Surg Open. 2017;8:18-23. | ||
| 34620304 |
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Individual participant data that underlie the results reported in this article, after deidentification
Beginning 3 months and ending 5 years following article publication
Researchers who provide a methodologically sound proposal. Proposals should be directed to erika.sasha@ui.ac.id. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years after publication at a third party website (link in process will be updated to be included)
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Other | Patients receive 200 ml regular drinking water with zero-calorie sweetener, 2 hours prior to surgery |
|
|
Hyperglycaemia-related complications, such as surgical site infection, aspiration, prolonged length of hospital stay
| Up to 1 week postoperative or discharged from hospital stay |
| Background |
| Robinson KN, Cassady BA, Hegazi RA, Wischmeyer PE. Preoperative carbohydrate loading in surgical patients with type 2 diabetes: Are concerns supported by data? Clin Nutr ESPEN. 2021 Oct;45:1-8. doi: 10.1016/j.clnesp.2021.08.023. Epub 2021 Sep 3. |
| 26197803 | Background | Pogatschnik C, Steiger E. Review of Preoperative Carbohydrate Loading. Nutr Clin Pract. 2015 Oct;30(5):660-4. doi: 10.1177/0884533615594013. Epub 2015 Jul 21. |
| 24417824 | Background | Bilku DK, Dennison AR, Hall TC, Metcalfe MS, Garcea G. Role of preoperative carbohydrate loading: a systematic review. Ann R Coll Surg Engl. 2014 Jan;96(1):15-22. doi: 10.1308/003588414X13824511650614. |
| 33526980 | Background | Lin MW, Chen CI, Cheng TT, Huang CC, Tsai JW, Feng GM, Hwang TZ, Lam CF. Prolonged preoperative fasting induces postoperative insulin resistance by ER-stress mediated Glut4 down-regulation in skeletal muscles. Int J Med Sci. 2021 Jan 11;18(5):1189-1197. doi: 10.7150/ijms.52701. eCollection 2021. |
| 30116862 | Background | Elias KM, Stone AB, McGinigle K, Tankou JI, Scott MJ, Fawcett WJ, Demartines N, Lobo DN, Ljungqvist O, Urman RD; ERAS(R) Society and ERAS(R) USA. The Reporting on ERAS Compliance, Outcomes, and Elements Research (RECOvER) Checklist: A Joint Statement by the ERAS(R) and ERAS(R) USA Societies. World J Surg. 2019 Jan;43(1):1-8. doi: 10.1007/s00268-018-4753-0. |
| 11254464 | Background | Soop M, Nygren J, Myrenfors P, Thorell A, Ljungqvist O. Preoperative oral carbohydrate treatment attenuates immediate postoperative insulin resistance. Am J Physiol Endocrinol Metab. 2001 Apr;280(4):E576-83. doi: 10.1152/ajpendo.2001.280.4.E576. |
| 10198313 | Background | Thorell A, Nygren J, Hirshman MF, Hayashi T, Nair KS, Horton ES, Goodyear LJ, Ljungqvist O. Surgery-induced insulin resistance in human patients: relation to glucose transport and utilization. Am J Physiol. 1999 Apr;276(4):E754-61. doi: 10.1152/ajpendo.1999.276.4.E754. |
| 25593845 | Background | Gutch M, Kumar S, Razi SM, Gupta KK, Gupta A. Assessment of insulin sensitivity/resistance. Indian J Endocrinol Metab. 2015 Jan-Feb;19(1):160-4. doi: 10.4103/2230-8210.146874. |
| 28121636 | Background | Duggan EW, Carlson K, Umpierrez GE. Perioperative Hyperglycemia Management: An Update. Anesthesiology. 2017 Mar;126(3):547-560. doi: 10.1097/ALN.0000000000001515. |
| 26248016 | Background | Gillis C, Carli F. Promoting Perioperative Metabolic and Nutritional Care. Anesthesiology. 2015 Dec;123(6):1455-72. doi: 10.1097/ALN.0000000000000795. |
| 27554250 | Background | Makuuchi R, Sugisawa N, Kaji S, Hikage M, Tokunaga M, Tanizawa Y, Bando E, Kawamura T, Terashima M. Enhanced recovery after surgery for gastric cancer and an assessment of preoperative carbohydrate loading. Eur J Surg Oncol. 2017 Jan;43(1):210-217. doi: 10.1016/j.ejso.2016.07.140. Epub 2016 Aug 10. |
| 28321553 | Background | Albalawi Z, Laffin M, Gramlich L, Senior P, McAlister FA. Enhanced Recovery After Surgery (ERAS(R)) in Individuals with Diabetes: A Systematic Review. World J Surg. 2017 Aug;41(8):1927-1934. doi: 10.1007/s00268-017-3982-y. |
| 18331374 | Background | Gustafsson UO, Nygren J, Thorell A, Soop M, Hellstrom PM, Ljungqvist O, Hagstrom-Toft E. Pre-operative carbohydrate loading may be used in type 2 diabetes patients. Acta Anaesthesiol Scand. 2008 Aug;52(7):946-51. doi: 10.1111/j.1399-6576.2008.01599.x. Epub 2008 Mar 7. |
| 23200124 | Background | Awad S, Varadhan KK, Ljungqvist O, Lobo DN. A meta-analysis of randomised controlled trials on preoperative oral carbohydrate treatment in elective surgery. Clin Nutr. 2013 Feb;32(1):34-44. doi: 10.1016/j.clnu.2012.10.011. Epub 2012 Nov 7. |
| 32107317 | Background | Alimena S, Falzone M, Feltmate CM, Prescott K, Contrino Slattery L, Elias K. Perioperative glycemic measures among non-fasting gynecologic oncology patients receiving carbohydrate loading in an enhanced recovery after surgery (ERAS) protocol. Int J Gynecol Cancer. 2020 Apr;30(4):533-540. doi: 10.1136/ijgc-2019-000991. Epub 2020 Feb 26. |
| 32252984 | Background | Talutis SD, Lee SY, Cheng D, Rosenkranz P, Alexanian SM, McAneny D. The impact of preoperative carbohydrate loading on patients with type II diabetes in an enhanced recovery after surgery protocol. Am J Surg. 2020 Oct;220(4):999-1003. doi: 10.1016/j.amjsurg.2020.03.032. Epub 2020 Mar 30. |
| 29512047 | Background | Gachabayov M, Senagore AJ, Abbas SK, Yelika SB, You K, Bergamaschi R. Perioperative hyperglycemia: an unmet need within a surgical site infection bundle. Tech Coloproctol. 2018 Mar;22(3):201-207. doi: 10.1007/s10151-018-1769-2. Epub 2018 Mar 6. |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |