Carbohydrate Loading in Type 2 Diabetes Mellitus

NCT06687811 | Completed

• 1 other identifier: IndonesiaUAnes093
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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

Conditions

Diabetes Mellitus Type 2

Keywords

Carbohydrate loading; Type 2 Diabetes Mellitus; Perioperative blood glucose; Insulin resistance

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Abnormal blood glucose incidence

  Preoperative, 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative

• Complications

  Up to 1 week postoperative or discharged from hospital stay

Study Arms (2)

Carbohydrate loading (CHO) group

ACTIVE COMPARATOR

Patient received preoperative carbohydrate loading of 200 ml Maltodextrin 12.5%, given 2 hours before the operation

Other: preoperative carbohydrate loading

Control

PLACEBO COMPARATOR

Patient received preoperative regular drinking water of 200 ml with zero-calorie sweetener, given 2 hours before the operation

Other: Placebo

Interventions

preoperative carbohydrate loading OTHER

Patients receive 200 ml drink containing Maltodextrin 12.5%, 2 hours prior to surgery

Also known as: CHO

Carbohydrate loading (CHO) group

Placebo OTHER

Patients receive 200 ml regular drinking water with zero-calorie sweetener, 2 hours prior to surgery

Also known as: Control

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Controlled type 2 diabetes mellitus with any treatment
• BMI \<30 kg/m2
• Non-major elective surgery

You may not qualify if:

• Subject refusal
• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSUPN Cipto Mangunkusumo

Central Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (19)

• 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.

  PMID: 12230794 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.

  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.

  PMID: 34620304 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.

  PMID: 26197803 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.

  PMID: 24417824 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.

  PMID: 33526980 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.

  PMID: 30116862 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.

  PMID: 11254464 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.

  PMID: 10198313 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.

  PMID: 25593845 BACKGROUND

• Duggan EW, Carlson K, Umpierrez GE. Perioperative Hyperglycemia Management: An Update. Anesthesiology. 2017 Mar;126(3):547-560. doi: 10.1097/ALN.0000000000001515.

  PMID: 28121636 BACKGROUND

• Gillis C, Carli F. Promoting Perioperative Metabolic and Nutritional Care. Anesthesiology. 2015 Dec;123(6):1455-72. doi: 10.1097/ALN.0000000000000795.

  PMID: 26248016 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.

  PMID: 27554250 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.

  PMID: 28321553 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.

  PMID: 18331374 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.

  PMID: 23200124 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.

  PMID: 32107317 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.

  PMID: 32252984 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.

  PMID: 29512047 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff of Departement of Anesthesiology and Intensive Care, Division of Cardiac Anesthesia

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 14, 2024
• Study Start: June 22, 2023
• Primary Completion: December 20, 2023
• Study Completion: January 31, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: 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)

Locations

ID (1)