Study Results
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Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2023-06-22
2024-01-31
Brief Summary
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* Does carbohydrate loading affects perioperative blood glucose and insulin resistance in type 2 diabetes mellitus patients undergo surgery?
* How are the incident of perioperative hyperglycemia and hypoglycemia between subjects who receive placebo compared with subjects who receive carbohydrate loading
* How are the hyperglycemia-related complications comparison between two groups?
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:
* randomized to carbohydrate loading (CHO) group or placebo
* checked for preoperative, intraoperative, postoperative blood glucose, and preoperative and postoperative insulin level
* evaluated for any hyperglycaemia-related complications
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Carbohydrate loading (CHO) group
Patient received preoperative carbohydrate loading of 200 ml Maltodextrin 12.5%, given 2 hours before the operation
preoperative carbohydrate loading
Patients receive 200 ml drink containing Maltodextrin 12.5%, 2 hours prior to surgery
Control
Patient received preoperative regular drinking water of 200 ml with zero-calorie sweetener, given 2 hours before the operation
Placebo
Patients receive 200 ml regular drinking water with zero-calorie sweetener, 2 hours prior to surgery
Interventions
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preoperative carbohydrate loading
Patients receive 200 ml drink containing Maltodextrin 12.5%, 2 hours prior to surgery
Placebo
Patients receive 200 ml regular drinking water with zero-calorie sweetener, 2 hours prior to surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI \<30 kg/m2
* Non-major elective surgery
Exclusion Criteria
* Geriatric patients with frailty score \>4
* Subjects with critical illness
* Subjects received steroid treatment
* Subjects received total parenteral nutrition
* Subjects with intestinal obstruction
* Subjects with impaired liver function
18 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Aries Perdana
Staff of Departement of Anesthesiology and Intensive Care, Division of Cardiac Anesthesia
Locations
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RSUPN Cipto Mangunkusumo
Central Jakarta, Jakarta Special Capital Region, Indonesia
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Duggan EW, Carlson K, Umpierrez GE. Perioperative Hyperglycemia Management: An Update. Anesthesiology. 2017 Mar;126(3):547-560. doi: 10.1097/ALN.0000000000001515.
Gillis C, Carli F. Promoting Perioperative Metabolic and Nutritional Care. Anesthesiology. 2015 Dec;123(6):1455-72. doi: 10.1097/ALN.0000000000000795.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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IndonesiaUAnes093
Identifier Type: -
Identifier Source: org_study_id
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